USE OF HOMEMADE BLENDERIZED FORMULA IN GASTROSTOMY TUBE DEPENDENT PEDIATRIC PATIENTS WITH FEEDING INTOLERANCE: A RETROSPECTIVE ANALYSIS
A Thesis
Presented in Partial Fulfillment of the Requirements for
the Degree Master of Science in the Graduate
School of The Ohio State University
By
Ashley Lynn Bronston, B.S. Graduate Program in Allied Medical Professions
The Ohio State University 2016
Master’s Examination Committee:
Dr. Marcia Nahikian-Nelms, Advisor
Dr. Wendelin Burdo-Hartman
Dr. Colleen Spees
Dr. Jill Clutter
i
Copyright by
Ashley Lynn Bronston, B.S.
2016
ii
Abstract
BACKGROUND: The use of blenderized foods for tube feedings is becoming more popular in response to exploring alternative options to commercial formulas.1 Such formulations have been documented to improve gastrointestinal symptoms, including gagging and retching.2,3 However, research that demonstrates the safety and efficacy of homemade blenderized formulas (HBF) is limited with regard to nutritional adequacy, weight maintenance, quality of life and gastrointestinal (GI) symptom alleviation.
METHODS: This study was a retrospective chart review. Patients were identified from a pilot study conducted in 2014-15. Data extracted for each patient included demographic characteristics, diagnoses, anthropometric measurements, an initial commercial formula prescription, a dietitian supervised transition plan, 5-day dietary histories of homemade blenderized recipes, scores from the Pediatric Quality of Life Inventory questionnaires
(Gastrointestinal Symptoms Module), and notes derived from the caregiver interviews.
Nutritional adequacy was assessed using the Nutrition Data System for Research (NDSR) to assess formula volume, energy, macronutrients, and micronutrients.4 The nutritional adequacy of each HBF recipe was evaluated by comparing HBF delivery of energy and
27 key nutrients (including fiber) to the participant’s dietary recommendations, based on age and gender. Weight was monitored and compared throughout study visits using the
ii Cerebral Palsy Gross Motor Function Classification System (CP GMFCS) Level 5-Tube
Fed Growth Charts. The presence or absence of gastrointestinal symptoms was documented at each outpatient visit. Finally, health related quality of life was evaluated using the Pediatric Quality of Life Inventory (PEDsQL) – Gastrointestinal Symptoms
Module.
INCLUSION CRITERIA: Four youth, between the ages of 2 and 18 years, diagnosed with a neurodevelopmental disability, were on enteral feeding via gastrostomy tube > 3 months, and identified with persistent GI symptoms.
RESULTS: Subjects presented with a mean of 3.5 GI symptoms. All subjects reported some degree of symptom alleviation during the intervention and post intervention, 75% of GI symptoms were resolved. The mean weight loss was 2.53 pounds + 4.14. On average, caregivers answered only 5 of the 14 domains on the PEDsQL due to the subjective nature of some questions. HBF was superior in the provision of nutrients for
Subjects 1 and 2. In Subject 3, commercial formula was identified as the more nutritionally adequate formula, but only by two nutrients. The commercial formula and HBF in subject 4 was nutritionally comparable, with both delivering 20 nutrients according to their clinical recommendations.
CONCLUSIONS: HBF alleviated most GI symptoms for the subjects in this study, especially symptoms related to diarrhea, retching and vomiting. Weight and nutrient intake must be closely monitored for potential variability. Inferences cannot be drawn from the PEDsQL for quality of life due to the high percentage of incomplete questions
iii
by caregivers. Homemade blenderized formula may be nutritionally comparable to commercial formula prescriptions, but require close monitoring and intervention by a
Registered Dietitian Nutritionist (RDN).
iv
Acknowledgments
To my hard working mentor, Dr. Marcia Nahikian-Nelms: You inspire me day in and day out with your tireless efforts, clinical expertise, kind demeanor, and priceless knowledge. I will be forever grateful that our lives crossed paths. A big thanks to my
Nationwide Children’s Hospital cheerleaders: Carol Williams and Wendelin Burdo-
Hartman. Both of you have guided me through this experience and have kept me on track. Thank you for supporting me! Also, thank you Dr. Jill Clutter and Dr. Colleen
Spees for being a part of this team.
To my family, thank you for repeatedly reassuring me that I would graduate on those late night phone calls. This was a hard road, but I would not have done it without your love and support. To my high school friends: you have given me the support I needed, in order to become who I am today. To my Mansfield Field Hockey girls: our years together went by way too quickly. I will never forget the love I felt when we were all crowded in my living room to find out into which program I was accepted. MUFH will always have a piece of my heart.
Finally, this experience would not have been the same without my beloved Med
Diet family. In two years, most of us went from strangers to best friends. You are what I love most about Columbus. The memories we created here will never be forgotten. I love you all! v
Vita
May 16, 1992 ...... Born – Princeton, New Jersey
June 2010 ...... Bordentown Regional High School
May 2014 ...... B.S. Dietetics & Sports Nutrition,
Mansfield University
May 2016 ...... Combined MS/DI Program in Medical
Dietetics, The Ohio State University
Field of Study
Major Field: Allied Medicine
vi
Table of Contents
Abstract ...... ii Acknowledgments ...... v Vita ...... vi List of Figures ...... xii Chapter 1: Introduction ...... 1 Background and Significance of the Problem ...... 1 Problem Statement ...... 2 Purpose of Study ...... 2 Research Objective ...... 3 Research Questions ...... 3 Chapter 2: Literature Review ...... 8 Introduction ...... 8 Prevalence of Undernutrition in Developmental Disabilities ...... 9 Enteral Nutrition ...... 12 Commercial Formulas ...... 15 Homemade Blenderized Formulas (HBF) ...... 19 Commercial Whole Food Formulas ...... 27 Liquid Hope™ ...... 27 Real Food Blends™ ...... 28 Compleat Pediatric® ...... 29 Pediatric Nutrient Requirements ...... 30 Cerebral Palsy Specific Nutrition Needs ...... 34 Conclusion ...... 35 Chapter 3: Methodology ...... 36 vii
Research Design ...... 36 Research Questions ...... 37 Participant Selection ...... 38 Eligibility ...... 39 Instruments ...... 39 Data Collection ...... 42 Data Analysis ...... 44 Chapter 4: Results and Discussion ...... 45 Subjects ...... 45 Weight ...... 47 Nutritional Adequacy ...... 49 Subject 1 ...... 49 Subject 2 ...... 53 Subject 3 ...... 56 Subject 4 ...... 59 Gastrointestinal Symptoms ...... 62 Quality of Life ...... 63 Overall Nutritional Adequacy ...... 65 Initial Follow-Up Visit and RDN Intervention ...... 65 Homemade Blenderized Formula Nutrient Concerns ...... 67 Weight ...... 69 Food Variety ...... 70 Specific Nutrient Profiles ...... 71 Calcium ...... 71 Vitamin D ...... 76
viii
Iron ...... 80 Magnesium ...... 85 Sodium ...... 91 Zinc ...... 96 GI Symptoms ...... 101 PEDsQL Modified Questionnaire ...... 102 Limitations ...... 102 Need for Future Study ...... 104 Chapter 5: Use of Homemade Blenderized Formula in Gastrostomy Tube Dependent Pediatric Patients with Feeding Intolerance: A Retrospective Analysis ...... 106 Appendix B: Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module Sample ...... 130 Appendix C: Cerebral Palsy Gross Motor Function Classification System (CP GMFCS) Level 5- Tube Fed Growth Charts ...... 136 Appendix D: Follow-Up Telephone Log and Script ...... 140 Appendix E: Diet History Form (with sample) ...... 143 Appendix F: Homemade Blenderized Formula Sources of Energy ...... 146 Appendix G: Homemade Blenderized Formula Sources of Calcium ...... 148 Appendix H: Homemade Blenderized Formula Sources of Potassium ...... 150 Appendix I: Pediatric Quality of Life Inventory - Modified Questionnaire ...... 152
ix
List of Tables
Table 1: MyPlate Food Group Recommendations66 ...... 31
Table 2. National Institutes of Health: Dietary Reference Intakes for Vitamins7,68–70 ..... 32
Table 3. National Institutes of Health: Dietary Reference Intakes for Vitamins71 ...... 32
Table 4. National Institutes of Health: Dietary Reference Intakes for Micronutrients70,7233
Table 5. National Institutes of Health: Dietary Reference Intakes for Micronutrients70,7233
Table 6. Primary Medical Diagnoses of Subjects 1-4 ...... 46
Table 7. Initial Commercial Formula Prescription at Visit 1 ...... 46
Table 8. Subject 1: Nutrient Comparison to Standard ...... 52
Table 9. Subject 2: Nutrient Comparison to Standard ...... 55
Table 10. Subject 3: Nutrient Comparison to Standard ...... 58
Table 11. Subject 4: Nutrient Comparison to Standard ...... 61
Table 12. Effect of HBF on Individual Gastrointestinal Symptoms after Transition as documented by Caregiver Interview ...... 62
Table 13. Effect of HBF on Gastrointestinal Symptoms after Transition (continued) as documented by Caregiver Interview ...... 63
Table 14. Symptom Alleviation after HBF Study ...... 63
Table 15. National Institutes of Health: Dietary Reference Intake Calcium ...... 72
Table 16. Calcium Rich Foods from Dietary Records ...... 75 x
Table 17. National Institutes of Health: Dietary Reference Intake Vitamin D ...... 77
Table 18. Vitamin D Rich Food from Dietary Records ...... 79
Table 19. National Institutes of Health: Dietary Reference Intake Iron ...... 81
Table 20. Iron Rich Foods from Dietary Records ...... 84
Table 21. National Institutes of Health: Dietary Reference Intake Magnesium ...... 86
Table 22. Magnesium Rich Food from Dietary Records ...... 90
Table 23. National Institutes of Health: Dietary Reference Intake Sodium ...... 92
Table 24. Sodium Rich Foods from Dietary Records ...... 95
Table 25. National Institutes of Health: Dietary Reference Intake Zinc ...... 96
Table 26. Zinc Rich Foods from Dietary Records ...... 100
xi List of Figures
Figure 1. Criteria for Selecting Homemade Blenderized Formula Candidates by Laura
Schoenfeld6,24 ...... 26
Figure 2. Comparison of Weights throughout Study Visits ...... 48
Figure 3. Subject 1: Nutrient Delivery ...... 51
Figure 4. Subject 2: Nutrient Delivery ...... 54
Figure 5. Subject 3: Nutrient Delivery ...... 57
Figure 6. Subject 4: Nutrient Delivery ...... 60
Figure 7. Calcium (mg) Intake Study Visits 1-3 ...... 74
Figure 8. Vitamin D (mcg) Intake Study Visits 1-3 ...... 78
Figure 9. Iron (mg) Intake Study Visits 1-3 ...... 83
Figure 10. Magnesium (mg) Intake Study Visits 1-3 ...... 88
Figure 11. Sodium (mg) Intake Study Visits 1-3 ...... 93
Figure 12. Zinc (mg) Intake Study Visits 1-3 ...... 98
xii
Chapter 1: Introduction
Background and Significance of the Problem
Homemade blended formulas (HBF) were first introduced in the 12th century, and later again in the 1800’s, but with poor nutritional outcomes.5 Blenderized food given through a tube increased the risk of infection, contributed to tube occlusion, and did not provide nutritional consistency.5 Sterile commercial formulas of known nutrient composition eventually displaced HBF feedings. Despite the fact that commercial formulas are shelf stable and controlled, symptoms of feeding intolerance, particularly gagging and retching behaviors, can be seen to dramatically decrease when the commercial formula is partially or fully replaced with HBF.2,6
This feeding method is gaining popularity in response to commercial formula intolerance. Homemade blenderized formulas utilize whole foods to supplement standard formulas.1 Patients and caregivers have claimed that homemade blenderized formulas have also allowed for normalization of the feeding process, greater volume tolerance, and have facilitated a transition to oral feeding. Optimal HBF outcomes are noted when patients meet feeding criteria and oversight is provided by a registered dietitian nutritionist (RDN).6
1
However, it is difficult to make claims about gastrointestinal improvements without solid research. To date, there are no published randomized controlled trials of
HBF or large populations to demonstrate that homemade blenderized formulas are nutritionally adequate, can alleviate GI symptoms and/or improve quality of life. Though positive anecdotal reports do exist on these areas of interest, only one peer-reviewed study with a sample of thirty-three children has found that HBF may decrease gagging and retching behaviors in children with feeding intolerance and post-fundoplication surgery.2 More evidence is needed to support the safety and efficacy of homemade blenderized formula in pediatric patients.
Problem Statement
Due to the gap in research, there is currently inadequate evidence to support the safety and efficacy of homemade blenderized formula in pediatric patients with gastrostomy tube dependence and feeding intolerance.
Purpose of Study
The purpose of this study was to complete a retrospective chart review to assess the efficacy of using homemade blenderized formula in gastrostomy tube dependent pediatric patients with feeding intolerance.
2
Research Objective
The objective of this study was to evaluate whether homemade blenderized formulas could be used as an alternative to commercial formula without major alterations in nutritional content and without undesirable changes in the subject’s health. Medical records, dietary histories, and PEDsQL questionnaires were reviewed in a sample of four pediatric patients with gastrostomy tube dependence and feeding intolerance in order to gain insight on the effects of homemade blenderized formula. Data was analyzed to measure nutritional adequacy, gastrointestinal symptom alleviation, weight, and quality of life after a successful transition to homemade blenderized formula was accomplished.
Research Questions
The following questions were based upon the sample of four pediatric subjects with gastrostomy tube dependence and feeding intolerance at a Midwestern Children’s
Hospital:
1. Will homemade blenderized formula be nutritionally adequate in the provision of
(a) energy: calories, (b) macronutrients: carbohydrates, protein, fat, water, (c)
micronutrients: calcium, copper, folate, iron, magnesium, manganese, niacin,
phosphorus, potassium, riboflavin, selenium, sodium, thiamin, vitamin A, vitamin
B12, vitamin B6, vitamin C, vitamin D, vitamin E, vitamin K, zinc, and (d) fiber?
2. Will homemade blenderized formulas be nutritionally comparable to the original
nutrition prescription of commercial formula?
3
3. Will the use of homemade blenderized feedings enable pediatric patients to
maintain or gain weight appropriate to their individual needs as measured by the
Cerebral Palsy Gross Motor Function Classification System (CP GMFCS) Level
5-Tube Fed Growth Charts?
4. Will the use of homemade blenderized formulas result in a reduction of GI
symptoms as measured by caregiver interview documentation?
5. Will the caregivers of children receiving homemade blenderized formulas report
an improvement in quality of life as measured by the Pediatric Quality of Life
Inventory – Gastrointestinal Symptoms Module?
4 List of Definitions
Adequate Intake (AI): established when evidence is insufficient to develop a recommended dietary allowance and is set at a level assumed to ensure nutritional adequacy.7
Bolus Feeding: A set amount of formula delivered four to eight times per day; each 8 feeding lasting about 15 to 30 minutes.
Cerebral Palsy: A group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. 9
Developmental Disability: A lifelong disability that affects people before they reach age 22 and substantially limits functioning ability in three or more life activities such as self- care, receptive and expressive language, learning, mobility, self-direction, independent living, and employability.10
Dietary Reference Intake (DRI): The general term for a set of reference values used to plan and assess nutrient intakes of healthy people. These values vary by age and gender, and include: Recommended Dietary Allowance (RDA), Adequate Intake (AI), and Tolerable Upper Intake Level (UL).7
Dysphagia: describes problems during the action of swallowing of fluids and/or food. 11
5
Enteral Nutrition: The provision of food or nutrients beyond the esophagus via a tube either to the stomach or small intestines.12
Failure to Thrive: A state of undernutrition due to inadequate caloric intake, inadequate caloric absorption, or excessive caloric expenditure. Failure to thrive is often defined as a weight for age that falls below the 5th percentile on multiple occasions or weight deceleration that crosses two major percentile lines on a growth chart. 13
Food Aversions: Selectively refuse to eat certain foods related to the taste, texture, smell, and/or appearance of these particular foods. The fear of trying new foods, results in a limited diet and nutritional deficiencies.14
Food Security: Food security exists when all people, at all times, have physical and economic access to sufficient, safe and nutritious food that meets their dietary needs and 15 food preferences for an active and healthy life.
Gastrostomy Tube: A tube placed into the stomach to provide nutrition and medication for patients unable to feed themselves.16
(GMFCS)-5: The Gross Motor Function Classification System- Level V indicates that children have no means of independent mobility and all areas of motor function are limited.
Holliday-Segar Equation: the standard method of calculating maintenance fluid requirements in pediatrics (100mL/kg for the 1st 10 kilograms of weight; 50mL/kg for the 2nd 10 kg of weight; 20mL/kg for remaining weight).17
Homemade Blenderized Formula: Any formula that a parent makes that modifies standard formula with real foods. It could be a commercial formula with a small amount
6
of baby food added, or three meals a day of blended food with commercial formula at night, or a complete diet of homemade blended foods, or many options in between.18
Malnutrition: Defined as an imbalance between nutrient requirement and intake, resulting in cumulative deficits of energy, protein, or micronutrients that may negatively affect growth, development, and other relevant outcomes.19
Nissen Fundoplication: A surgical procedure that corrects gastroesophageal reflux (GERD) by creating an improved valve mechanism at the bottom of the esophagus. It is meant to prevent the flow of acids upward.20
Oral Motor Dysfunction: Difficulty controlling the muscles of the mouth, including the tongue, lips and those involved in swallowing.
Recommended Dietary Allowance (RDA): The average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%-98%) healthy people.7
Registered Dietitian Nutritionist (RDN): Registered Dietitian Nutritionists are food and nutrition experts who have met the following criteria to earn the RDN credential: 1) completed a minimum of a bachelor’s degree, 2) completed an accredited supervised practice program, 3) passed a national examination and 4) completed continuing professional educational requirements.21
Retching: Labored rhythmic activity of the diaphragm and anterior abdominal wall musculature that precedes vomiting and is the first part of the emetic reflex.22
7
Chapter 2: Literature Review
Introduction
This literature review examines the current research regarding the use of homemade blenderized formulas in gastrostomy tube dependent children with developmental disabilities. A developmental disability, according to the Developmental
Disabilities Assistance and Bill of Rights Act, is defined as a lifelong disability that affects people before they reach age 22 and substantially limits functioning ability in three or more life activities such as self-care, receptive and expressive language, learning, mobility, self-direction, independent living, and employability.10 Disabilities placing an individual at high risk for nutritional deficiency include cerebral palsy, craniofacial anomalies and many other genetic syndromes such as Down syndrome which are associated with oral motor and swallowing problems.23
When food intake is insufficient over an extended period of time, gastrostomy tubes are often the preferred route of nutrition as this maintains the normal path for digestion and absorption. However, children may become intolerant to their commercial formulas and experience gastrointestinal distress. The movement for using whole foods for enteral nutrition has gained popularity despite the availability of commercially prepared, complete formulas.24 Healthcare providers need to evaluate the risks and
8 benefits carefully for each individual patient before recommending or deciding to counsel their families to incorporate HBF into feedings. The research review will cover the prevalence of undernutrition within the study population, enteral nutrition, pediatric nutrient needs, and a comprehensive review of HBF and commercial formulas.
Prevalence of Undernutrition in Developmental Disabilities
In 1999, there were between 3,200,000 and 4,500,000 individuals with developmental disabilities in the United States, and recent studies indicate that individuals with developmental disabilities comprise 1.2-1.65 percent of the United
States population.10 Individuals whose disabilities occur during the critical developmental period will frequently have severe disabilities that are likely to be life-long.10
Complexities in the medical condition often require a multidisciplinary approach for treatment, including fields of neuroscience, genetics, dietetics, and other medical specialties.25
Registered Dietitian Nutritionists (RDNs) are a fundamental part of the healthcare team due to the profound prevalence of undernutrition in children with diagnosed developmental disabilities (DD). Children with DD are at least three times more likely to experience sensitivity to oral food intake, pain during bowel movements, diarrhea, constipation, vomiting, as well as swallowing impairments when compared to children with typical development.26 Swallowing impairment due to poor coordination of muscular reflexes can lead to reduced food intake, malnutrition, and recurrent pulmonary
9
aspiration.27 This population is also susceptible to oral motor dysfunction, food aversions and excessive drooling and gagging.
One retrospective chart review of 294 children and adults with severe DD, found that many of them had more than one clinical feeding problem. Most (92%) had dysphagia; 72% had failure to thrive; 67% had gastroesophageal reflux, and 65% had a history of recurrent respiratory infections or chronic suppurative lung disease. Feeding and nutritional problems were considered severe enough to warrant gastrostomy tube insertion in approximately 50% of the patients.27
Optimal nutrition is the cornerstone of health and well-being for all children.
Weight gain and growth along predicted trajectories help to reassure families and health professionals that the child is thriving.28 Sangermano and colleagues found that despite massive caregiver commitment and medical advice, 13 (44%) of their 30 pediatric patients were at risk for malnutrition.29 In spite of nutritional and dietary measures, daily caloric intake of these children was often insufficient resulting in an impaired macronutrient balance.29 Continued malnutrition within this clinical population may also cause derangements in body composition, as well as osteoporosis.
Throughout one’s life, bone will undergo continuous reorganization. The dynamic nature is primarily observed in childhood and adolescence, when active mineralization of bone occurs. Developmental disorders and medications, specifically antiepileptic drugs
(phenytoin, primidone, and phenobarbital) can adversely affect this dynamic process, thereby lowering the “fracture threshold”.30 The risk of fractures within this group is also
10
significantly increased due to inadequate nutrition, decreased exposure to sunlight, and anticonvulsant use.28 Nutritional rehabilitation in tube fed children with CP, may result in significant increases of bone mineral content, fat mass and height.31 Vitamin D and calcium supplementation may be able to delay osteopenia while increasing bone mineral density in severely disabled children with epilepsy.32
In extreme cases, death can occur from nutrition-related complications. A study in
Malawi revealed that in their inpatient-based Severe Acute Malnutrition (SAM) program, neurological disabilities were second only to HIV as a risk factor for mortality.23,33
Childhood disability is extremely common in resource-poor settings, ranging from 19-60 children per 1000. Children born to underweight women are reported to have an increased risk of neurologic damage and delayed mental development. There remains an urgent need for nutrition and disability programs to operate together to prevent abnormal fetal neurodevelopment.34
Sullivan and colleagues launched the Oxford Feeding Study to analyze the prevalence and severity of feeding and nutritional problems associated with children with neurological impairments.35 A validated questionnaire was sent to 377 parents from the
Oxford Register of Early Childhood Impairments, with a return rate of 72%. Among these respondents, 59% had constipation, 22% had significant problems with vomiting, and 31% suffered at least one chest infection in the previous six months. Feeding problems were also significant: 89% needed help with feeding, 56% choked on food, and
20% described feeding as stressful. Prolonged feeding times of > 3 hours per day was
11
reported by 28%. Of the 271 respondents, 255 (83%) had never been assessed by a RDN.
The results highlight the need for nutritional assessment as part of overall care due to the severity of nutritional issues within this population.
One reason that healthcare professionals may not identify undernutrition in a timely manner may be due to the unusual anthropometric measurements of this population. Measurements can be difficult to interpret properly because they are influenced by both nutritional and non-nutritional factors (i.e. growth deficit). Red flags such as flattening growth curves, inadequate TSF measurements, or a zBMI > two standard deviations should be inspected during a nutrition assessment by a RDN.
Caregivers may also view low weight as a positive factor, which further increases malnutrition risk. Caring for non-ambulatory children with severe combined developmental and cognitive disabilities can be a daunting task for caregivers as a child increases in size.36 Allowing a child to have a low body weight will make the child easier to transfer and care for; however, undernourished children may never reach their developmental potential, are much more susceptible to infection, and may experience other medical complications.37 With inadequate calories and protein, children may have delayed wound healing, experience episodes of fatigue, impaired immune function, and have an altered mental health status.
Enteral Nutrition
Enteral nutrition is nourishment given through a tube into a functioning gastrointestinal tract. In children with developmental disabilities, the use of a gastrostomy
12
tube is often unavoidable and is warranted if the child is unable to adequately feed orally for an extended period of time (> 3 months).24 Reasons for inadequate oral feeding may include: neurological impairments, airway abnormalities, inborn errors of metabolism, cyclic vomiting, gastrointestinal dysmotility, severe reflux, and/or clinical intolerance to oral feeding.24
Alternative feeding routes are advocated for patients with severe DD and nutritional/growth problems as it has been shown to restore linear growth, normalize weight, improve health and quality of life, and decrease frequency of hospitalizations.27
The goal of enteral nutrition therapy is to maintain or restore nutritional status to patients who fail to have sufficient oral intake. Enteral nutrition has also been documented to reduce infectious complications and maintain the integrity of intestinal flora.38 The life expectancy of children with severe cerebral palsy (CP) has increased partially as a result of improved attention to nutrition requirements and the growing use of enteral nutrition.28,39
Growth rates and restoration of weight are major benefits of enteral support.
Gatrostomy feedings allow for nutritional improvement and catch-up growth. Height was found to improve, along with a positive trend in weight and body mass index (BMI).40
Normalization of weight is typically achieved when tube feedings are started within eight years of the central nervous system insult. Height may be normalized if feedings are begun in the first year.40 On the other hand, Dahlseng found that gastrostomy tube feeding was associated only with improved weight and BMI, but not height.41 In children
13
fed by gastrostomy tube, undernutrition was almost absent and obesity was slightly enhanced.42 There remains controversy over whether or not gastrostomy feedings may increase the risk of death. It is difficult to attribute GT with mortality risk, as mortality may be directly related to the underlying medical condition.43
Although enteral nurition has its benefits, risks and complications may ensue after gastrostomy tube placement. Gastroesophageal reflux (GERD) is a common nonsurgical complication after a percutaneous gastrostomy tube (PEG) procedure. The patient may experience heartburn, regurgitation, dysphagia, respiratory difficulty, and damage to the esophageal mucosa.44 It is unclear whether the placement of a PEG actually increases the risk of GERD or if the children, particularly those with a developmental disability, have gastric dysmoility leading to GERD symptoms.24 Nissen fundoplication surgery may be performed to reduce the risk of aspiration or prevent severe GERD.2 The surgical procedure involves wrapping the fundus of the stomach around the intra-abdominal esophagus to reinforce the closing function of the lower esophageal sphincter.24,44 While this may improve GERD symptoms, the fundoplication surgery may cause dysphagia, gas-bloat syndrome, abnormal gastric motility, gastric hypersensitivity, dumping syndrome, and the increased occurance of gagging and retching behaviors.45
Due to these possibilities, caregivers often delay the gastrostomy tube procedure.
Martinez-Costa and colleagues published a study with 26 disabled children with GT and found, parents/caregivers had high satisfaction with GT (91%) for their children. Families
(87%) stated that they would have accepted the procedure earlier if they had known it
14
would result in such positive outcomes. Patient management and family dynamics improved throughout the course of the trial. Therefore, it is crucial for healthcare professionals to advocate for its use, if found appropriate.
Commercial Formulas
Enteral nutrition during the 1960’s and 70’s was confined to only the sickest children. Experience with enteral nutrition was limited due to the small population of patients receiving nutrition through tube feeding. Infants in desperate need of tubes were given food through supplemental formula. As they grew, parents added pureed foods through the tubing, which was essentially what we now know as a homemade blenderized formula.46
As technology continued to advance in the 1970’s, formula companies were developing more nutritionally adequate products due to the influx and improvement of scientific research and technology. As commercial formulas became more widely available, safer, and more cost effective, homemade blenderized formulas became a less attractive option.24 The commercially pre-made formulas were convenient for caregivers, easily quantifiable for healthcare professionals, and were safer for patient consumption.
The risk of microbial contamination and labor intensity were the primary reasons that
HBF was abandoned in healthcare facilities.1
Since the composition of enteral formula is fixed by manufacturers and the Food and Drug Administration, the possibility of complications arising from imbalanced
15
nutrient intake is less likely than with oral diets.47 However, studies documenting nutrient complications from enteral nutrition are not readily available in literature. Nutrient complications including fluid imbalance, electrolyte imbalance, and acid-base disturbances occur in tube fed patients; yet, one cannot directly equate those issues to feeding because nutrient deficiencies may be due to the underlying disease or medical treatment.
One retrospective chart review analyzed 150 records from the Tube Feeding
Clinic at Children’s Hospital of Wisconsin, to determine the prevalence of nutrient deficiencies with commercial formulas.48 Within the sample, no deficiencies of Vitamin
D or E were found. Ferritin concentrations were below lower limits of the age appropriate range of normal in 30 of 122 (25%), and hemoglobin was below lower limits in 12 of 139 patients (9%). One patient each had vitamin A, calcium, phosphorus, and magnesium serum concentrations below age appropriate lower limits. Below normal serum zinc was found in 43 of 142 (30%) patients. Ninety-one of 134 patients (68%) had below normal selenium levels, and 29 of 126 (23%) had both zinc and selenium deficiency. Despite the multiple deficiencies discovered within the data, the patients were guaranteed to be getting 50% or more of their calories from enteral formula. Non-infant formulas are designed to be nutritionally adequate for children receiving 100% of their Recommended
Dietary Allowance (RDA) for calories. Decreasing the formula volume gives rise to the possibility of macro, and micronutrient deficiencies.
16
Two published case studies demonstrated possible nutrient deficiencies in children receiving primary nutrition from enteral formulas. The first case was a male child who was born at 39 weeks gestation. Breastfeeding was established before discharge, but at 4 weeks he was diagnosed as failure to thrive. During the next 12 months, catch-up growth was goal. The child received full strength enteral formula (MCT
Peptide 2+) through a GT. At the age of 38 months, the child was found to be anemic and had a severe vitamin C deficiency. Further investigation demonstrated that that the mother was storing the formula at room temperature, which can result in vitamin C degradation. Also, there may have been a potential drug interaction with phenobarbital.
The child also had a complex medical history including episodic diarrhea, bloody stools, vomiting, and pain within limbs.49
The other case study examined a 3-year old patient with a medical history of cerebral palsy, developmental delay, and seizure disorder. Due to persistent vomiting of oral formula, he underwent Nissen fundoplication and a GT placement. The child was prescribed an amino acid based formula (Neocate One+) and had normal energy balance.
Despite adequate formula intake, the child was reported to have a vitamin C, vitamin A and zinc deficiency. Review with the caregiver demonstrated correct mixing of formula.
It was hypothesized that the phenobarbital may have altered the vitamin metabolism. The drug has been reported to increase hepatic synthesis of ascorbic acid in rats and induce cytochrome enzymes, which are responsible for ascorbic acid degradation. Also, amino- acid based formulas generally have a lower concentration of micronutrients; therefore, more volume must be given to achieve the RDA of vitamins/minerals.50 17
In contrast, a prospective study of 12 pediatric patients receiving enteral feeds comprising of more than 50% of their caloric needs for 6 months, reported no deficiencies of calcium, copper, ferritin, folic acid, iron, magnesium, phosphorus, riboflavin, selenium, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin
D, and zinc. Even though some children had low caloric intakes (52-69% of their clinical recommendation), no serum micronutrient deficiencies were found. Three-day food diaries documented adequate intake of all micronutrients. In the same study, serum measurements taken after 6 months of under feeding demonstrated nutrient deficiencies in some subjects: riboflavin (n = 2), folate (n = 3), iron (n = 1), vitamin B6 (n = 1), and vitamin A (n = 2). This may indicate that prolonged feeding (> 6 months) under caloric goals may result in micronutrient deficiencies.
Similarly, a study from France examined 64 children receiving >50% of caloric needs for greater than 6 months.51 Concentrations of iron, zinc, copper, selenium, and vitamins A, D, E, and C were measured in plasma samples. Twelve children (19%) had iron deficiency. A high 25-hydroxyvitamin D concentration was recorded in 20% of the children, but none had associated hypercalcemia. Fifty-two children (81%) had low zinc concentrations in both plasma and erythrocytes. When children were given supplemental fiber, they had significantly lower concentrations of zinc, calcium, phosphorus and vitamin D. Researchers concluded that long-term enteral nutrition that does not meet energy requirements could lead to micronutrient deficiencies. Additionally it was concluded that fiber supplementation could reduce the bioavailability of zinc, calcium, phosphorus and vitamin D. 18
After reviewing the known literature, it has been noted that when children are consuming 100% of their caloric goals, there should only be negligible concern for micronutrient deficiencies with commercialized formula. However, as the volume decreases, it becomes more likely that deficiencies will occur.
Homemade Blenderized Formulas (HBF)
Using blenderized foods in enteral nutrition has gained interest in recent years.1
Patients and caregivers have claimed that homemade blenderized formulas have also allowed for normalization of the feeding process, greater volume tolerance, and have facilitated a transition to oral feeding. Homemade blenderized formulas are defined as
“any formula that a parent makes that modifies standard formula with real foods”.18 It could be a commercial formula with a small amount of baby food added, or three meals a day of blended food with commercial formula at night, or a complete diet of homemade blended foods, or many options in between.18
Controversy exists around the use of homemade blenderized formulas. Healthcare providers need to weigh the risks and benefits carefully for each individual patient and provide caregivers with a waiver that protects against liability in the case of poor outcomes.24 Until there is additional research supporting the efficacy and safety of homemade blenderized diets, this method of feeding should be used only when caregivers have requested the formula change and fully understand the associated risks.24
19
Caregivers may consent to the use of HBF for a variety of reasons. First, it gives the caregiver some control over which foods are included in the child’s diet. Blenderized foods also give older children the chance to choose what they wish to consume. HBF may allow for a greater variety of nutrients and incorporate phytochemicals into the diet, which are not present in standard polymeric formula. Lastly, there is evidence to support that HBF may alleviate some GI symptoms for children who are intolerant to their commercial formulas.2
Feeding is not solely to meet physiological needs; it also must fulfill psychosocial needs. Food tends to lose its social aspect in patients with enteral nutrition.
Family integration and expression of affection through food vanishes with the use of commercial formulas.52 Using HBF allows the feeding tube to be viewed as a “second mouth” rather than a medical necessity.46 The use of HBF may also support psychosocial values and allow the family to express their identity through the use of food items.
A recent cross-sectional study conducted by Hurt, et al. 2015, found that in a sample of 54 adult patients dependent on gastrostomy feeds, 55.5% of them had used
HBF in the past.35 Patients in the cohort used HBF for a median of 4 days per week, ranging from 1-7 days. Thirty of the patients who used HBF provided reasons for using
HBF with the most common reasons being “more natural” (n=13), like eating what their family eats (n=10), and can tolerate HBF better (n=9).
Homemade blenderized formulas may also have the added benefit of providing additional fiber and phytochemicals to the patient. Phytochemicals are a large group of
20
plant-derived compounds, which have demonstrated significant health benefits conferred from fruits, vegetables, beans, cereals, and plant-based beverages.53 Although they are non-essential nutrients for sustaining life, they have many beneficial properties.
Phytochemicals have been shown to modulate oncogenic processes through their antioxidant and anti-inflammatory activities and their ability to mimic the chemical structure of hormones. Researchers are only beginning to understand the complete effects of phytochemicals, but in the future they may be combined with cancer treatments.54
Another potential benefit of HBF is through the alleviation of persistent gastrointestinal symptoms. Currently, multiple methods have been tried to lessen the occurrence of GI distress associated with gastrostomy feedings. Physicians may attempt to vent the stomach or change to jejunal feedings while dietitians alter tube feed recommendations. Dietitians may recommend slowing the goal rate, switching to continuous feeds, varying concentrations, or changing the type of formula. When these strategies prove unsuccessful, the persistent symptoms can affect both the child and the family’s quality of life.
In response to parental frustration, healthcare members at Cincinnati Children’s
Hospital Medical Center (CCHMC) trialed the use of pureed or “blenderized” foods for patients experiencing gagging and retching symptoms post-fundoplication surgery.2 This was the first clinical trial using blenderized gastrostomy tube feeds to manage complications associated with enteral feeding.24 Blenderized foods were directly inserted into the gastrostomy tube via bolus feedings. Children receiving the HBF required a 14”
21
French or larger to prevent clogging during feeds. The base of the diet was either commercially prepared baby food or formula. Team dietitians then created individualized diets and instructed parents on preparation, storage, and delivery. Parents of 17 of the 33 children (52%) reported a 76% to 100% decrease in gagging and retching after their child started the blenderized diet. No parents found their child’s symptoms to be exacerbated by the use of HBF. Additionally, 19 of the 33 (57%) were discovered to have an increase in oral intake on the blenderized diet. The remaining patients consumed the same amount or continued to eat nothing by mouth. The positive effects of the diet appear to be sustained, when families reported continued improvement 2 months after therapy.
Since the Pentiuk et al. 2011 publication, other departments within CCHMC have experimented with blenderized diets to decrease feeding intolerance, specifically gagging and retching behaviors in patients with gastrostomy tubes. The dietitians in the pulmonary unit used blenderized enteral diets and found improvements in enteral feeding tolerance in their patients with cystic fibrosis.24,55
While examining the benefits of HBF, it is also important to consider the risks when making the decision for a patient. Preparation of HBF requires the caregiver to devote extra time during the day to properly compose the feeds. The typical duration of meals is between 60 and 120 minutes due to episodes of food regurgitation or resistance.29 Mealtimes may already be stressful, prolonged and not enjoyable times for families; therefore, extending this process may not be in the best interest of the caregivers. Economical reasons may also persuade families against HBF. Although the
22
estimated daily cost for HBF is $6.20 compared with $8.00 for the equivalent calories using commercial formulas, insurance will not cover the cost of HBF. The family would need to pay for the diet independently.2 Children whose families receive formula through federally funded programs (i.e. Women Infants and Children) may not be able to afford the switch to HBF, or have access to a Registered Dietitian Nutritionist (RDN) for assistance for planning.
The use of HBF also requires a highly experienced dietitian to be able to create the individualized diet and make modifications over time. The nutrient content of HBF can vary widely and the caloric content requires adjustment.56 Variability in the recipe preparation should be expected, as this is a common theme documented with homemade blenderized recipes.24,57 It may be beneficial to use a validated nutrient analysis program in combination with professional judgment to promote consistency. The quality factors that influence effectiveness of treatment, such as pH, fluidity, stability and nutritional composition of HBF varies greatly on ingredients used, preparation and the storage process.58 Therefore, it is recommended to use a commercial base of either formula or baby food to ensure nutritional adequacy.
The use of HBF requires additional handling, which heightens the risk for bacterial contamination. Risk factors include: the environment in which the recipes are prepared, poor attention to hygiene, improper storage, and extended disposal time. In
2006, a study was conducted to assess homemade tube feeding formulas in two educational hospitals in Isfahan for bacterial contamination. Researchers discovered that
23
bacterial contamination of these foods was much higher than the Food and Drug
Administration (FDA) standards. Currently FDA guidelines view unacceptable bacterial contamination as one of the following: aerobic microorganisms >10³ CFU/g in one sample, contamination of over 10³ CFU/g in three or more samples, coliform count over
3 organisms/g, or a positive sample for L. monocytogenes or salmonella.59 The study found that in 42 handmade enteral samples, 16 samples (76%) had total viable counts greater than 103 CFU/g in the first sampling time and 17 samples (81%) had total viable counts greater than 103 CFU/g in the second sampling time. Also, 11 (52%) had coliform contamination in the first sampling time, and this reached 76% (16 samples) in the second sampling time; therefore, indicating that microbial safety issues may exist for homemade enteral solutions. A patient who requires continuous feeding would not be an acceptable HBF candidate because feedings that last longer than 2 hours are at risk for bacterial contamination. It is vital that medical centers and households follow protocols for preparation, handling, and storage of enteral feeds to prevent the growth of microorganisms.
Other considerations to take into account when discussing HBF are: the age of the patient, medical stability, feeding administration, G-tube materials, food allergies, gastric volume limitations, immunosuppressive therapy, and fluid restriction.1 Homemade blenderized formulas should not be introduced if the child is less than 6 months old.24
The use of HBF may not be deemed appropriate for medically unstable patients, those with non-healed tube sites, or those undergoing immunosuppressive therapy given the
24
potential for infection associated with food-borne illness. These homemade feedings should also be administered through bolus feeds rather than continuous infusions because the blend should not be at room temperature for greater than 2 hours.1 Patients also require a 14” French feeding tube or bigger, due to the increased risk of tube occlusion.
Dietitians need to assess for multiple food allergies and if the patient requires a fluid restriction. A fluid restriction < 30 ounces per day, may not allow the child to reach his/her clinical energy requirements through HBF.24 Summaries of these recommendations are found in Figure 1.
25
6,24
. Criteria for Selecting Homemade Blenderized Formula Candidates by Laura Schoenfeld 1
Figure Figure
Figure 1. Criteria for Selecting Homemade Blenderized Formula Candidates by Laura Schoenfeld6,24
26 Commercial Whole Food Formulas
New types of commercial formulas have emerged on the market due to the demand for more whole food products. Products such as Liquid Hope™, Real Food
Blends™ and Compleat Pediatric® are using real, whole foods to create enteral formulas.
Caregivers may question if these formulas can be used as another alternative to both HBF and standard polymeric formulas. The purpose of this review is to highlight their ingredients, nutrient composition, and current literature supporting the product. A review of these products can allow parents and RDNs to make an informed choice when it comes to their usage within the child’s diet.
Liquid Hope™
Liquid Hope™ is advertised as a nutritionally complete formula that utilizes 17 organic and whole-food ingredients. The formula has a low carbohydrate content (16%) with high proportions of protein (46%) and fat (31%). The formula has gained popularity due to the marketing of vegan, no added sugar, dairy-free, gluten-free and GMO-free buzzwords. The product is sold as single 12-ounce pouches that require no refrigeration prior to opening. Both Medicare and Medicaid will cover the formula under their insurance policies at $7.99 per serving. Liquid Hope™ does not assure nutritional consistency or content. The company states: “Liquid Hope undergoes regular nutritional assessment and lab testing. However, as with all real food products, the nutrient levels may vary a bit due to growing season, soil, and weather conditions.”60 The manufacturers
27
have provided a detailed nutrient analysis on their company web site. The product promotes eight years of tested research; however, the only literature available to the public is based on anecdotal reports. A representative from their office, when contacted by phone, stated that the product is currently undergoing clinical testing to better support the anecdotal claims of “normalizing blood glucose, alleviating GI distress, improved energy levels and quality of life”.60
Real Food Blends™
Real Food Blends™ are composed of 5-7 ingredients in each meal. The product comes in three meal varieties (orange chicken, carrots & barley; quinoa, kale & hemp; and salmon, oats & squash). The nutrition information presented on the website offers only the minimally required nutrients for a food label. The macronutrient content varies slightly between the meals, but is estimated to contain 34% carbohydrate, 20% protein and 46% fat. The promotional material for this product states that it was “intentionally designed for someone who was living off 6-8 cans of standard formula per day, to switch to 1-2 cans with Real Food Blends™ to add nutritional variety to the diet”.61 Additional information from the company states that the product was not intended to be nutritionally complete and will require supplementation.61 The product is also covered through many insurance policies, which may be a benefit to some families. Manufacturers refrain from using corn syrup, preservatives, and artificial flavorings.
28
Compleat Pediatric®
Compleat Pediatric® formulated through Nestle Health Science, is a whole food ingredient blend intended to be a complete source of nutrition for patients with intolerance to standard formula. The formula is primarily composed of chicken, peas, carrots, tomatoes and cranberry juice concentrate. The ingredient list also includes added micronutrients. The added vitamins and minerals, allow the formula to meet the DRI for
25 micronutrients.62 The company offers a detailed nutrient analysis of their product. The macronutrient composition is approximately 51% carbohydrate, 15% protein and 34% fat. The manufacturers advertise Compleat Pediatric® for its added blend of bone essential nutrients (calcium, phosphorus, magnesium, zinc, and vitamins D, C & K) and added fiber for digestive health.62
While both Liquid Hope™ and Compleat Pediatric® can be used as sole sources of nutrition, Real Food Blends™ are intended to be used only as a supplemental meal source. Similar to both HBF and standard formulas, if the children are not receiving
100% of their estimated energy requirements, it is recommended that they also take a multivitamin to assure nutritional needs are met. Liquid Hope™ incorporates a variety of food ingredients with an added vitamin blend. Real foods can be seen for the first 11 ingredients before the company begins adding supplemental micronutrients. In contrast,
Real Food Blends™ only use whole foods but it remains nutritionally inadequate.
Finally, Compleat Pediatric® uses few natural products and relies on most of its nutrition to come from supplemental nutrients. Currently, there is no literature that exists on the
29
nutritional adequacy of whole food formulas in comparison with HBF or standard formulas. Parents and healthcare providers need to investigate what is best for the individual child and family.
Pediatric Nutrient Requirements
Protein and micronutrient requirements of children with DD are similar to their age-matched peers. However, special attention should be given to meeting their vitamin
D and calcium goals to ensure proper bone health. There is no standard method for determining energy requirements for children with DD/CP because of the heterogeneity, high variability in motor activity, and the variations in body composition.63 Ambulatory children will have similar energy needs to their healthy age-matched peers, whereas those who are non-ambulatory have significantly lower energy requirements.64 There still remains a debate on the influence of muscle spasticity and dyskinesia on energy requirements of children with CP. These factors were once thought to increase caloric needs, yet new findings are showing that it may not affect energy needs as much as once believed.65
As a starting point in nutrition rehabilitation, dietitians may want to consider increasing energy intake by 10% above the child’s current intake.28 Children with DD have similar dietary recommendations in comparison to their healthy peers. The amount of food recommended from each food group varies by age (see Table 1)
30
Food Groups: Daily Servings by Age 2-3 Yrs 4-8 Yrs 9-13 Yrs 14-18 Yrs 19-30 Yrs Grains (oz) 3 oz 5 oz 5-6 oz 6-8 oz 6-8 oz Vegetables (cup) 1 cup 1 ½ cups 2- 2 ½ cups 2 ½ - 3 cups 2 ½ - 3cups Fruits (cup) 1 cup 1-1 ½ cups 1 ½ cups 1 ½ - 2 cups 2 cups Dairy (cup) 2 cups 2 ½ cups 3 cups 3 cups 3 cups Protein (oz) 2 oz 4 oz 5 oz 5-6 oz 5 ½ -6 ½ oz Table 1: MyPlate Food Group Recommendations66
However, Bills found that HBF recipes may require additional servings from the food groups in order to meet nutrient recommendations.36 The American Heart
Association recommends for those aged 2 years and older, that dietary recommendations rely on fruits, vegetables, whole grains, low-fat dairy, beans, fish and lean meat.67 Other pediatric recommendations echo the recent U.S. dietary guidelines, which emphasize low intakes of saturated and trans fat, cholesterol, sugar, and sodium; while maintaining an energy intake and physical activity level appropriate to maintain healthy weights.67
Vitamin and mineral recommendations vary individually based on the DRI (Dietary
Recommended Intakes) for age and gender. Below are the standard recommendations for children birth to 18 years old, with or without DD. Vitamins and minerals were reported based on their relevance to the study data (see Tables 2-5).
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Vitamin Vitamin C Vitamin D Vitamin E Vitamin K A (µg) (mg) (µg) (mg) (ug) Infants 0-6m 400* 40* 10* 4* 2* 7-12m 500* 50* 10* 5* 2.5* Children 1-3y 300 15 15 6 30* 4-8y 400 25 15 7 55* Males 9-13 y 600 45 15 11 60* 14-18 y 900 75 15 15 75* Females 9-13 y 600 45 15 11 60* 14-18 y 700 65 15 15 75* Table 2. National Institutes of Health: Dietary Reference Intakes for Vitamins7,68–70 Numerical values represent the Recommended Dietary Allowance for each nutrient. An asterisk (*) signifies that Adequate Intake was used.
Thiamin Riboflavin Niacin Vit B6 Folate Vit B12 (mg) (mg) (mg) (mg) (µg) (µg) B1 B2 B3 Infants 0-6m 0.2* 0.3* 2* 0.1* 65* 0.4* 7-12m 0.3* 0.4* 4* 0.3* 80* 0.5* Children 1-3y 0.5 0.5 6 0.5 150 0.9 4-8y 0.6 0.6 8 0.6 200 1.2 Males 9-13 y 0.9 0.9 12 1.0 300 1.8 14-18 y 1.2 1.3 16 1.3 400 2.4 Females 9-13 y 0.9 0.9 12 1.0 300 1.8 14-18 y 1.0 1.0 14 1.2 400 2.4 Table 3. National Institutes of Health: Dietary Reference Intakes for Vitamins71
Numerical values represent the Recommended Dietary Allowance for each nutrient. An asterisk (*) signifies that Adequate Intake was used.
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Calcium Copper Iron Magnesium Manganese (mg) (µg) (mg) (mg) (mg) Infants 0-6m 200* 200* 0.27* 30* .003* 7-12m 260* 220* 11 75* 0.6* Children 1-3y 700 340 7 80 1.2* 4-8y 1000 440 10 130 1.5* Males 9-13 y 1300 700 8 240 1.9* 14-18 y 1300 890 11 410 2.2*
Females 9-13 y 1300 700 8 240 1.6* 14-18 y 1300 890 15 360 1.6* Table 4. National Institutes of Health: Dietary Reference Intakes for Micronutrients70,72
Numerical values represent the Recommended Dietary Allowance for each nutrient. An asterisk (*) signifies that Adequate Intake was used.
Phosphorus Potassium Selenium Sodium Zinc (mg) (g) (µg) (g) (mg) Infants 0-6m 100* 0.4* 15* 0.12* 2* 7-12m 275* 0.7* 20* 0.37* 3 Children 1-3y 460 3.0* 20 1.0* 3 4-8y 500 3.8* 30 1.2* 5 Males 9-13 y 1250 4.5* 40 1.5* 8 14-18 y 1250 4.7* 55 1.5* 11 Females 9-13 y 1250 4.5* 40 1.5* 8 14-18 y 1250 4.7* 55 1.5* 9 Table 5. National Institutes of Health: Dietary Reference Intakes for Micronutrients70,72
Numerical values represent the Recommended Dietary Allowance for each nutrient. An asterisk (*) signifies that Adequate Intake was used.
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Cerebral Palsy Specific Nutrition Needs
Nutrition and growth deficits are often under-recognized, or considered to be a low priority matter in children with cerebral palsy. Undernutrition in this population can have serious consequences including: growth failure, decreased cerebral function, impaired immune function, reduced circulation, and diminished respiratory muscle strength.73 Poor growth has been linked to poor health and social participation, as well as an increased mortality risk.74 Therefore, RDNs should be indispensable health care members in the overall medical management for these patients.
Many children with CP have decreased energy requirements in comparison with their neurotypical peers, and these differences increase with the severity of motor impairment. The energy requirements for children with severe CP (GMFS-Level IV-V), who use a wheelchair for mobility, have been reported to be between 60-70% of those of neurotypical children.64,74 Walker et al. 2012, used the doubly labeled water method to determine energy requirements in children with cerebral palsy.65 Thirty-two children with
CP (representing all GMFCS levels) were compared to sixteen neurotypical children. At the population level, children with cerebral palsy had significantly lower energy requirements than neurotypical children. Non-ambulatory children had significantly lower energy requirements than ambulatory children. No statistical differences in energy requirements were found between the ambulant children and neurotypical children. This highlights that GMFCS level contributes to the variability in energy requirements.
There is no evidence to suggest that children with CP have different protein
34
requirements from their age-matched typically developing peers; therefore, the RDA recommendation for typically developing children can be used.73 Also, standard recommendations for micronutrients can be used, but with special attention to vitamin
D.73
Conclusion
A wide variety of enteral nutrition formulas exist to support the plethora of disease states. Standard polymeric formulas are indicated for most patients who require nutrition support, since they are classically sources of complete nutrition. When a patient is being receiving 100% of their estimated energy needs, it appears unlikely that nutrient deficiencies will develop. Standard polymeric formulas are reliable as the nutrient content is established and validated. Patients who are tolerating the formula well may find it in their best interest to remain on the commercial formula.
On the other hand, HBF may contain some phytochemicals and fiber, which are lacking in standard polymeric formulas. The HBF diet has been shown to be effective in decreasing gagging and retching behaviors while advancing oral intake in children with gastrostomy tube dependence, feeding intolerance, and who have undergone Nissen fundoplication. The mechanism by which HBF diets improve GI symptoms has not been elucidated. If done properly, HBF can be safe and healthful while improving patient satisfaction with gastrointestinal intolerance. As a possible alternative to commercial formulas, it is important to take into consideration: time, insurance coverage, nutritional adequacy, and food safety.
35 Chapter 3: Methodology
Research Design
This study was a retrospective chart review. Patients were identified from a pilot study conducted in 2014-15, whose research goal was to observe and measure the effects of homemade blenderized formulas on gastrostomy tube dependent pediatric patients in regards to their symptoms of feeding intolerance.3 Additional information was obtained for this analysis by review of medical and dietetic records. Data extracted for each patient included demographic characteristics, diagnoses, anthropometric measurements, an initial commercial formula prescription, a dietitian supervised transition plan, 5-day dietary histories of homemade blenderized recipes, scores from the Pediatric Quality of Life
Inventory (PEDsQL Gastrointestinal Symptom Module) and notes from caregiver interviews.
Diet histories were analyzed using the Nutrition Data System for Research
(NDSR) to assess formula volume, energy, macronutrients, and micronutrients. The nutritional adequacy of each HBF recipe was evaluated by comparing HBF delivery of energy and 27 key nutrients (including fiber) to the participant’s dietary recommendations, based on age and gender. Weight was monitored and compared throughout study visits using the Cerebral Palsy Gross Motor Function Classification
36
System (CP GMFCS) Level 5-Tube Fed Growth Charts. The presence or absence of gastrointestinal symptoms was documented at each outpatient visit. Lastly, health related quality of life was evaluated using the Pediatric Quality of Life Inventory (PEDsQL) –
Gastrointestinal Symptoms Module.
The research objective of this study was to evaluate whether homemade blenderized formulas could be used as an alternative to commercial formula, without major alterations in nutritional adequacy, and without undesirable changes in the patient’s health.
Research Questions
The following questions were based upon data collected for the original study of four pediatric patients with gastrostomy tube dependence and feeding intolerance at a
Midwestern Children’s Hospital:
1. Will homemade blenderized formula be nutritionally adequate in the provision of
(a) energy: calories, (b) macronutrients: carbohydrates, protein, fat, water, (c)
micronutrients: calcium, copper, folate, iron, magnesium, manganese, niacin,
phosphorus, potassium, riboflavin, selenium, sodium, thiamin, vitamin A, vitamin
B12, vitamin B6, vitamin C, vitamin D, vitamin E, vitamin K, zinc, and (d) fiber?
2. Will homemade blenderized formulas be nutritionally comparable to the original
nutrition prescription of commercial formula?
3. Will the use of homemade blenderized feedings enable pediatric patients to
37
maintain or gain weight appropriate to their individual needs as measured by the
Cerebral Palsy Gross Motor Function Classification System (CP GMFCS) Level
5-Tube Fed Growth Charts?
4. Will the use of homemade blenderized formulas result in a reduction of GI
symptoms as measured by caregiver interview documentation?
5. Will the caregivers of children receiving homemade blenderized formulas report
an improvement in quality of life as measured by the Pediatric Quality of Life
Inventory – Gastrointestinal Symptoms Module?
Participant Selection
The study population included a sample of eleven pediatric patients that were recruited from clinics at a Midwestern Children’s Hospital. A staff research associate also screened for patients at the hospital’s Complex Health Care Clinic. Initial contact with the potential participant’s caregiver was managed using a screening telephone script and algorithm, developed by the research staff.
Of the 11 patients recruited for the original study, 4 successfully completed.
Unenrollment from the study occurred for a variety of reasons. Due to the complex medical nature of the children, it was common for participants to have unexpected illnesses or emergent health needs. Caregivers felt more comfortable using the commercial formula due to convenience, time constraints, and guaranteed nutritional composition. Other patients were unenrolled due to death or lack of caregiver follow-up.
38
Multiple attempts were made to reach caregivers and aid them with the transition; however, failure to follow through resulted in withdrawal from the study.
Eligibility
Subjects met the following criteria: (a) were between the ages of 2 and 18 years,
(b) diagnosed with a neurodevelopmental disability, (c) were on enteral feeding via gastrostomy tube > 3 months, and (d) identified with persistent gastrointestinal symptoms. Persistent symptoms were described as having constipation, diarrhea, retching, vomiting, gas, and/or abdominal pain for at least 4 days out of the week for minimum of one month.3 Caregivers were required to have sufficient literacy and fluency in English to understand the intervention and be capable of completing questionnaires.
Participants were included if food secure, as identified by the Food Insecurity Screen, a two-question survey validated for use in identifying families at risk for food insecurity
(See Appendix A).75
Patients were ineligible if diagnosed with either short gut syndrome or myelomeningocele, due to the condition’s extreme impact on GI function. Those who were identified as food insecure, or received commercial formula for more than 7 days after the HBF transition were also excluded.
Instruments
This section includes a brief description of instruments used to collect data in the original study that served as sources of data. To ensure that families met the inclusion
39
criteria for the original study, a two-item food security tool was used to identify families of young children who were at risk for food insecurity. The questionnaire was administered as a screening tool after consent. The two-item screening tool uses the
Household Food Security Survey Module (HFSSM) questions 1 and 2, which are most frequently endorsed among food insecure families. The questions asked (1) “Within the past 12 months we worried whether our food would run out before we got money to buy more” and (2) “Within the past 12 months the food we bought just didn't last and we didn't have money to get more.” An affirmative response to question 1 and/or question 2 had a sensitivity of 97% and specificity of 83% for identifying food insecure families.75
The Pediatric Quality of Life Inventory 3.0 Gastrointestinal Symptoms Module is a modular instrument designed to measure health related quality of life (HRQOL) in children and adolescents aged 2-18 years of age (see Appendix B).76 The HRQOL measurement is increasingly being used to gauge the impact of pediatric diseases and treatments from the prospective patients and their caregivers.77 The multidimensional instrument consists of physical, psychological, and social health dimensions. The scale requires a parent proxy for children aged 2-4 years; but allows children aged 5-18 years to self-report with administrator aid. Item scaling is dependent on a 5-point Likert scale from 0 (never) to 4 (almost always). The items are then reversed scored and linearly transformed to a 0-100 scale as follows 0=100, 1=75, 2=50, 3=25, 4=0. Scores are significantly lower for patients with (functional gastrointestinal diseases) FGIDs and organic GI diseases when compared with healthy controls.77 For the present study, the
40
data, previously collected in the original study, was analyzed to identify changes in GI symptoms and HRQOL with the transition to a homemade blenderized formula.
Nutrient analyses of data collected from the 5-day diet histories gathered in the original study, were conducted in the Clinical Research Center at The Ohio State
University. Dietary intake data was entered into the Nutrition Data Systems for Research software version 2014 (NDSR) developed by the Nutrition Coordinating Center (NCC),
University of Minnesota, in Minneapolis, MN. The NDSR is a dietary analysis software application that is used for the collection and analyses of dietary recalls, food records, menus and recipes.
This nutrient database is unique in that it offers standardized dietary assessment methods, interactive interview modules, immediate nutrient calculations, quality assurance features, many hard copy report options, and extensive data output files.4 The
NDSR version 2014 includes over 18,000 food items, 7,000 brand-name products, menu items from 23 leading restaurants, and a range of ethnic foods. Ingredient choices and preparation variants provide more than 160,000 possible food varients.4 The system has more nutrients and other food components than any other research quality food database.4
One hundred and sixty-five nutrients are available, along with a food group serving count system to facilitate the estimation of food group servings.4 The database is relied on heavily by hundreds of researchers at institutions across the United States.4
The food and nutrient composition data used by the NCC is acquired from the
USDA National Nutrient Database for Standard Reference. Sophisticated search
41
algorithms locate the food and prompts will standardize requests for more detail. When values for nutrients or food components are unavailable, the NCC will look for values from scientific journals with appropriate analytic methodologies, or contact food manufacturers.4 This allows the NDSR database to remain a superior source, since many other databases include only the nutrients that are found on the nutrition facts panel.
NDSR also remains up-to-date with new annual products in the marketplace, and takes into account product reformulation.
Data Collection
Data from patient medical records were recovered using Electronic Health Record
Software (EPIC). During outpatient visits in the original study, weight, height/length and head circumference was collected to monitor the development of the patient. Based on the patient’s age and gender, anthropometric values were evaluated for appropriate weight gain and maintenance by plotting them on the Cerebral Palsy Gross Motor
Function Classification System (CP GMFCS) Level- 5 Tube Fed Growth Charts (see
Appendix C).
Gastrointestinal intolerance was measured using multiple domains. Caregivers were first prompted via monthly phone calls to answer questions about their child’s GI symptoms, including questions regarding the occurrence of constipation, diarrhea, retching, vomiting, gas, or abdominal distention during the course of the original study
(see Appendix D). To further analyze GI intolerance, caregivers were asked to fill out the
Pediatric Quality of Life Inventory- Gastrointestinal Symptom Module questionnaire, at
42
each outpatient visit. The PEDsQL scoring system was used to look for reductions in gastrointestinal symptoms and assess for improvements in quality of life.
In the original study, the 5-day dietary histories (see Appendix E) were reviewed with the caregiver during each outpatient visit or via phone (if unable to make appointment) to ensure clarity. Specific information such as: the preparation method
(fried, baked, microwaved broiled, grilled, steamed, stewed, boiled, stir fried, raw), density form (i.e. grams of carrot in 1 cup diced, grated, and sliced), condition (fresh, frozen, canned), brand name, added ingredients (i.e. added butter, salt, oil), total HBF yield (fluid ounces), and portion sizes were addressed during the interview to guarantee that the research team had extracted precise information to assure accurate diet information. Food manufacturers were also contacted to assure that the correct nutrient information was obtained when clarification was required.
To perform dietary analysis of the nutrient information for this study, a second party review by a trained research assistant verified initial accuracy of data entry. Each individual food component was reviewed and compared to the original food history document. Final data assessment was conducted by the Clinical Research Bionutritionist who performed data cleansing by detecting and correcting inaccurate records from the dataset. The data cleansing removed inconsistencies that were caused by user entry errors. The data was exported to the research team as a Microsoft Excel spreadsheet and evaluated for the provision of kilocalories, carbohydrates, protein, fat, water, calcium, copper, fiber, folate, iron, magnesium, manganese, niacin, phosphorus, potassium,
43
riboflavin, selenium, sodium, thiamin, vitamin A, vitamin B12, vitamin B6, vitamin C, vitamin D, vitamin E, vitamin K, and zinc. Nutritional adequacy was based on the delivery of energy and 27 key nutrients to the patient and was determined by their calculated nutritional needs using the Recommended Dietary Allowances/Dietary
Reference Intake based on age and gender. Each blenderized formula recipe was then compared to the child’s original nutrition prescription of commercial formula for energy and key nutrients.
Data Analysis
An in depth descriptive analysis was conducted on both, weight and gastrointestinal symptomology for each participant. Individualized nutrient profiles were developed to identify nutrients of concern and to assess adequacy of the blenderized recipe. A comparison was drawn between the commercial formula prescription and homemade blenderized recipes to examine for areas of deficiency. Quality of life measures via the PEDsQL were scored and compared between the initial and final visit.
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Chapter 4: Results and Discussion
Subjects
The sample included four subjects. Age at the time of completion ranged from 5.3 to 16.5 years (median 6.6 years). All four study subjects were female. The primary diagnoses are summarized in Table 6. All subjects were gastrostomy tube dependent for their nutritional needs. Subject four was able to ingest food by mouth; however, typical intakes were less than 4 oz. per day and were not considered sufficient for growth and nourishment. All subjects were on a Miralax and/or Senokot to treat frequently occurring episodes of constipation. At the start of the study, three of the subjects fell below the
50%tile in BMI, based on the GMFCS Level 5 –TF female growth charts. The initial commercial formula prescriptions are provided in Table 7.
45
Primary Medical Diagnoses of Subjects 1-4 Subject 1 Subject 2 1p36 Deletion Syndrome Cerebral Palsy Gastroesophageal Reflux Disease Vomiting Athetoid Cerebral Palsy Chronic Constipation Hypothyroidism Hypotonia Chronic Constipation Developmental Delay Generalized Seizure Disorder Gastrostomy Tube Dependence Low Bone Density Gastrostomy Tube Dependence
Subject 3 Subject 4 Spastic Quadriplegic Cerebral Palsy Hypotonic Cerebral Palsy Gastroesophageal Reflux Disease Developmental Delay Acquired Microcephaly Gastroesophageal Reflux Disease Gastrostomy Tube Dependence Gastrostomy Tube Dependence Table 6. Primary Medical Diagnoses of Subjects 1-4
Initial Commercial Formula Prescription Energy Protein (kcal) (g) Subject 1 Formula: 400 gm of Neocate Jr (unflavored) + 1860 mL of free water 925 31 Feeding: 4 feeds/day: 2 x 300 mL and 2 x 250mL
Subject 2 Formula: 190 gm of Elecare Jr (unflavored) + 720 mL of free water 642 20 Feeding: 4 feeds/day of 180mL @ 90 mL/hr x 2 hrs (pump)
Subject 3 Formula: 16 scoops of Elecare Jr + 900 mL of water 717 22 Feeding: 3 feeds/day: 90mL/hr x 3.5 hrs
Subject 4 Formula: 220 mL of Pediasure 1.0 Feeding: continuous night feeding + 4 oz 3 1184 55 times/day orally
Table 7. Initial Commercial Formula Prescription at Visit 1
46
Weight
The most significant loss was seen in Subject 1, who lost 9.24 pounds over a six- month period. Her body mass index (BMI) dropped from a normal range between the 50-
75%tile (based on the GMFCS Level 5 – TF female growth charts) to below the
<50%tile. Subject 2 was also documented to have lost weight (2.42 pounds) during a shorter duration of 5 months. Although the decreased weights were concerning to the research staff, it was difficult to quantify what was considered to be clinically significant in this population. There is no clear consensus on the correct definition of ideal body weight in this population.78 The other two subjects maintained their initial body weight, with a slight gain in Subject 3 (1.76 pounds).
No significant changes in height were found. It is important to note that height measurement (via tape measure and knee calipers) may have been difficult to obtain on these children since they exhibited severe muscle stiffness and contractures. A representation of weight change over the course of the three visits is displayed in Table 9.
47
Comparison of Weights throughout Study Visits 35.0
30.0
25.0
20.0
Weight (kg) Weight 15.0
10.0
5.0 Day 1 Day 90 Day 180
0.0 Initial Weight Visit 2 Weight Visit 3 Weight (kg) (kg) (kg) Subject 1 31.6 29.1 27.4 Subject 2 23.6 24.0 22.5 Subject 3 15.7 14.8 16.5 Subject 4 12.9 13.7 13.0
Figure 2. Comparison of Weights throughout Study Visits
48
Nutritional Adequacy
Nutrient adequacy was defined as being 100% of its established clinical recommendation. A nutrient was considered to be inadequate when it registered to be
<100% of the clinical recommendation. The majority of the clinical recommendations were based on the nutrient’s Recommended Dietary Allowance (RDA), but the Adequate
Intake (AI) was used when an RDA value has not been established for that particular nutrient. The Holliday-Segar equation was used to calculate maintenance fluid requirements (water). Caloric goals were established based on previous RDN recommendations.
Subject 1
At the initial visit, the commercial formula prescription provided adequate levels of 10 nutrients and inadequate levels of 17 nutrients. Of the 27 total nutrients studied, 17 were delivered at suboptimal levels (<100% of RDA/AI). These nutrients included: energy (99%), carbohydrate (74%), vitamin A (79%), vitamin E (86%), vitamin K (50%), niacin (59%), B6 (77%), folate (69%), calcium (88%), phosphorus (59%), potassium
(27%), magnesium (46%), manganese (75%), selenium (68%), sodium (36%) and iron
(96%). Dietary fiber was absent within the formula and also considered to be inadequate based on its’ AI recommendation for optimal health.
When the subject returned on HBF for study Visit 2, the recipe provided 7 nutrients in adequate amounts. Twenty nutrients were found to be below the established threshold for nutritional adequacy. This was a 14% drop in the provision of adequate
49
nutrients. Dietary intervention was necessary at this stage to prevent further decline in adequacy and to help improve the HBF recipe. An additional one-ounce equivalent of grains and one tablespoon of molasses was recommended to increase caloric intake.
At visit 3, the participant had a notable increase (22%) in the delivery of adequate nutrients from visit 2. Adequate nutrient provision increased from 7 nutrients in visit 2, to
13 nutrients in visit 3. This would have not been likely to occur without the RDN monitoring and intervention. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that the HBF was actually slightly superior in regards to nutritional adequacy, by three nutrients. With RDN intervention, the two formulas were then closely comparable.
50
100% of its RDA/AI. Inadequate delivery =
>
Subject1: NutrientDelivery
Figure 3. Figure An adequate nutrient was defined as meeting <100% of RDA/AI. RDA was used when available.
Figure 3. Subject 1: Nutrient Delivery An adequate nutrient was defined as meeting >100% of its RDA/AI. Inadequate delivery = <100% of RDA/AI. RDA was used when available.
51
Subject 1: Nutrient Comparison to Standard Nutrient Rec Standard CF CF (%) V3 HBF V3 HBF (%) Energy, kcal 930 calc 925 99% 1182 127% Carbohydrate, g 130 RDA 96 74% 163 125% Protein, g 31 RDA 31 100% 45 145% Fat, g 30 AI 47 157% 42 140% Fiber, g 26 AI 0 0% 23 88% Water, mL 1732 Eq 1801 104% 1940 112% Vitamin A, µg 700 RDA 553 79% 2065 295% Vitamin C, mg 65 RDA 86 132% 101 155% Vitamin D, µg 15 RDA 18 120% 5 33% Vitamin E, mg 15 RDA 13 86% 7 47% Vitamin K, µg 75 AI 37 49% 50 67% Thiamin (B1), mg 1.0 RDA 1.2 120% 0.8 80% Riboflavin (B2), mg 1.0 RDA 1.9 190% 1.4 140% Niacin (B3), mg 14 RDA 8 57% 13 93% Vitamin B6, mg 1.2 RDA 0.9 75% 1.4 117% Folate, µg 400 RDA 277 69% 214 54% Vitamin B-12. µg 2.4 RDA 3.7 154% 4.3 179% Calcium, mg 1300 RDA 1148 88% 822 63% Copper, mg 0.89 RDA 1.2 135% 1.95 220% Phosphorus, mg 1250 RDA 740 59% 802 64% Potassium, mg 4700 AI 1264 27% 2764 59% Magnesium, mg 360 RDA 166 46% 347 96% Manganese, mg 1.6 AI 1.2 75% 4.7 300% Selenium, mcg 55 RDA 37 67% 53 96% Sodium, mg 1500 AI 535 36% 3199 213% Iron, mg 15 RDA 14 93% 9 60% Zinc, mg 9 RDA 9 100% 6 67% Table 8. Subject 1: Nutrient Comparison to Standard
Column Key: Rec = Clinical Recommendation; Standard = Dietary Intake Reference (DRI) that clinical recommendation was based; Calc = Previous RDN calculation; Eq = Clinical Equation; RDA = Recommended Dietary Allowance; AI = Adequate Intake; CF= Commercial Formula nutrient amount; CF%= Commercial Formula percentage of recommendation; HBF= Homemade Blenderized Formula nutrient amount; HBF%= Homemade Blenderized Formula percentage of recommendation
52
Subject 2
At the initial visit, the commercial formula prescription provided adequate levels of 8 nutrients and inadequate levels of 19 nutrients. Of the 27 total nutrients examined, 19 were delivered at suboptimal levels (<100% of RDA/AI). These nutrients included: energy (94%), carbohydrate (52%), vitamin A (88%), water (60%), vitamin D (67%), vitamin E (55%), riboflavin (78%), niacin (92%), vitamin B6 (50%), folate (63%), calcium (59%), phosphorus (43%), potassium (21%), magnesium (46%), manganese
(51%), selenium (43%), sodium (22%) and zinc (88%). Dietary fiber was absent within the formula and also considered to be inadequate based on its AI recommendation for optimal health.
When the subject returned on HBF for study Visit 2, the recipe was providing 10 nutrients in adequate amounts. Seventeen nutrients were found to be below our established threshold for nutritional adequacy. This was a 7% increase in the provision of adequate nutrients. Dietary intervention focused on increasing fluid delivery through bolus flushes of water in order to meet estimated fluid needs, and molasses was added as a source of energy, calcium, and iron.
At visit 3, the nutrient delivery remained stable. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that the
HBF was actually superior in regards to nutritional adequacy, by two nutrients.
53
s RDA/AI. Inadequate delivery = delivery Inadequate RDA/AI. s
100% of it of 100%
>
Figure 4. Subject 2: Nutrient Delivery Nutrient 2: Subject 4. Figure meeting as defined was nutrient adequate An RDA/AI. <100% of RDA available used was when
Figure 4. Subject 2: Nutrient Delivery
An adequate nutrient was defined as meeting >100% of its RDA/AI. Inadequate delivery = <100% of RDA/AI. RDA was used when available.
54
Subject 2: Nutrient Comparison to Standard Nutrient Rec Standard CF CF (%) V3 HBF V3 HBF (%) Energy, kcal 680 calc 642 94% 836 123% Carbohydrate, g 130 RDA 67 52% 106 82% Protein, g 20 RDA 20 100% 43 215% Fat, g 30 AI 31 103% 28 93% Fiber, g 31 AI 0 0% 10 32% Water, mL 1572 Eq 943 60% 1763 112% Vitamin A, µg 600 RDA 528 88% 1044 174% Vitamin C, mg 45 RDA 58 129% 15 33% Vitamin D, µg 15 RDA 10 67% 6 40% Vitamin E, mg 11 RDA 6 55% 2 18% Vitamin K, µg 60 AI 82 137% 44 73% Thiamin (B1), mg 0.9 RDA 1.3 144% 0.7 78% Riboflavin (B2), mg 0.9 RDA 0.7 78% 1.1 122% Niacin (B3), mg 12 RDA 11 92% 10 83% Vitamin B6, mg 1 RDA 0.5 50% 1.03 103% Folate, µg 300 RDA 190 63% 135 45% Vitamin B-12. µg 1.8 RDA 2.7 150% 2.3 128% Calcium, mg 1300 RDA 771 59% 803 62% Copper, mg 0.7 RDA 0.9 129% 0.6 86% Phosphorus, mg 1250 RDA 540 43% 700 56% Potassium, mg 4500 AI 945 21% 1405 31% Magnesium, mg 240 RDA 111 46% 158 66% Manganese, mg 1.6 AI 0.82 51% 2.2 138% Selenium, mcg 40 RDA 17 43% 54 135% Sodium, mg 1500 AI 328 22% 1083 72% Iron, mg 8 RDA 11 138% 8 100% Zinc, mg 8 RDA 7 88% 5 63% Table 9. Subject 2: Nutrient Comparison to Standard
Column Key: Rec = Clinical Recommendation; Standard = Dietary Intake Reference (DRI) that clinical recommendation was based; Calc = Previous RDN calculation; Eq = Clinical Equation; RDA = Recommended Dietary Allowance; AI = Adequate Intake; CF= Commercial Formula nutrient amount; CF%= Commercial Formula percentage of recommendation; HBF= Homemade Blenderized Formula nutrient amount; HBF%= Homemade Blenderized Formula percentage of recommendation
55
Subject 3
At the initial visit, the commercial formula prescription provided adequate levels of 18 nutrients and inadequate levels of 9 nutrients. Of the 27 total nutrients studied, 9 were delivered at suboptimal levels (<100% of RDA/AI). These nutrients included: energy (99%), carbohydrate (58%), water (73%), vitamin D (71%), potassium (37%), manganese (78%), selenium (95%), and sodium (37%). Dietary fiber was absent within the formula and also considered to be inadequate based on its AI recommendation for optimal health.
When the subject returned on HBF for study Visit 2, the recipe was providing 17 nutrients in adequate amounts. Ten nutrients were found to be below our established threshold for nutritional adequacy. This represents a 19% reduction in the provision of adequate nutrients. Dietary intervention was necessary at this stage to prevent further decline in adequacy and to help improve the HBF recipe. At this time, subject 3 was tolerating three HBF bolus feeds of 120mL, but was losing weight. Therefore, two additional feeds of 60mL were added as snacks into her daily regimen, in order to meet energy requirements. Daily table salt (1/2-1 tsp) was also recommended to increase the sodium content in her HBF. At visit 3, the participant had an increase in the delivery of adequate nutrients from visit 2. Adequate nutrient provision increased from 13 nutrients in visit 2, to 16 nutrients in visit 3. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that the commercial formula was actually better in regards to nutritional adequacy, by two nutrients.
56
its RDA/AI. its
available. when used was 100% of of 100% >
Delivery Nutrient 3: Subject 5. Figure meeting as defined was nutrient adequate An RDA RDA/AI. of = <100% delivery Inadequate
Figure 5. Subject 3: Nutrient Delivery
An adequate nutrient was defined as meeting >100% of its RDA/AI. Inadequate delivery = <100% of RDA/AI. RDA was used when available.
57
Subject 3: Nutrient Comparison to Standard Nutrient Rec Standard CF CF (%) V3 HBF V3 HBF (%) Energy, kcal 720 calc 717 99% 658 91% Carbohydrate, g 130 RDA 76 58% 92 71% Protein, g 21.7 RDA 22 101% 27 124% Fat, g 35 AI 35 100% 21 60% Fiber, g 19 AI 0 0% 11 58% Water, mL 1285 Eq 944 73% 1015 79% Vitamin A, µg 300 RDA 585 195% 648 216% Vitamin C, mg 15 RDA 65 433% 35 233% Vitamin D, µg 15 RDA 11 71% 6 40% Vitamin E, mg 6 RDA 7 117% 3 50% Vitamin K, µg 30 AI 93 310% 20 67% Thiamin (B1), mg 0.5 RDA 1.5 300% 1.0 200% Riboflavin (B2), mg 0.5 RDA 0.8 160% 1.5 30% Niacin (B3), mg 6 RDA 12 200% 13 217% Vitamin B6, mg 0.5 RDA 0.6 120% 1.4 280% Folate, µg 150 RDA 213 142% 405 270% Vitamin B-12. µg 0.9 RDA 3.0 333% 4.4 489% Calcium, mg 700 RDA 856 122% 625 89% Copper, mg 0.34 RDA 1.01 297% 0.37 109% Phosphorus, mg 460 RDA 603 131% 556 121% Potassium, mg 3000 AI 1101 37% 1138 38% Magnesium, mg 80 RDA 123 154% 115 144% Manganese, mg 1.2 AI .94 78% 1.68 140% Selenium, mcg 20 RDA 19 95% 28 140% Sodium, mg 1000 AI 369 37% 1844 184% Iron, mg 7 RDA 13 186% 9 129% Zinc, mg 3 RDA 8 267% 9 300% Table 10. Subject 3: Nutrient Comparison to Standard
Column Key: Rec = Clinical Recommendation; Standard = Dietary Intake Reference (DRI) that clinical recommendation was based; Calc = Previous RDN calculation; Eq = Clinical Equation; RDA = Recommended Dietary Allowance; AI = Adequate Intake; CF= Commercial Formula nutrient amount; CF%= Commercial Formula percentage of recommendation; HBF= Homemade Blenderized Formula nutrient amount; HBF%= Homemade Blenderized Formula percentage of recommendation
58
Subject 4
At the initial visit, the commercial formula prescription provided adequate levels of 20 nutrients and inadequate levels of 7 nutrients. Of the 27 total nutrients studied, 7 were delivered at suboptimal levels (<100% of RDA/AI). These nutrients included: energy (99%), vitamin D (47%), calcium (76%), potassium (47%), manganese (97%), and sodium (74%). Dietary fiber was minimally found within the formula and also considered to be inadequate based on its AI recommendation for optimal health.
When the subject returned on HBF for study Visit 2, the recipe was providing 24 nutrients in adequate amounts. Only 3 nutrients were found to be below our established threshold for nutritional adequacy. This was a 15% increase in the provision of adequate nutrients. Dietary intervention involved increasing oral intake of food to 425-525 kilocalories/day. The subject was also started on Liquid Centrum (1 tsp) and calcium/vitamin D supplements (600mg) every day. The supplements were not included in the nutrient analysis.
At visit 3, the participant had a decrease in the delivery of adequate nutrients from visit 2. Adequate nutrient provision decreased from 24 nutrients in visit 2, to 20 nutrients in visit 3. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that both formulas were nutritionally comparable for Subject 4. Vitamin supplements were not factored into the nutrient analysis.
59
100%of its RDA/AI. Inadequate delivery= <100% of >
used when available.
Delivery Nutrient 4: Subject 6. Figure meeting as defined was nutrient adequate An RDA was RDA/AI.
Figure 6. Subject 4: Nutrient Delivery
An adequate nutrient was defined as meeting >100% of its RDA/AI. Inadequate delivery = <100% of RDA/AI. RDA was used when available.
60
Subject 4: Nutrient Comparison to Standard Nutrient Rec Standard CF CF (%) V3 HBF V3 HBF (%) Energy, kcal 1200 calc 1184 99% 1991 166% Carbohydrate, g 130 RDA 137 105% 223 172% Protein, g 16 RDA 55 344% 61 381% Fat, g 30 AI 43 143% 101 337% Fiber, g 25 AI 4 16% 16 64% Water, mL 1385 Eq 1594 115% 1766 128% Vitamin A, µg 400 RDA 400 100% 704 176% Vitamin C, mg 25 RDA 68 272% 12 48% Vitamin D, µg 15 RDA 7 47% 1.9 13% Vitamin E, mg 7 RDA 10 143% 5.3 76% Vitamin K, µg 55 AI 66 120% 30 55% Thiamin (B1), mg 0.6 RDA 1.7 283% 1.1 183% Riboflavin (B2), mg 0.6 RDA 1.7 283% 1.9 317% Niacin (B3), mg 8 RDA 12 150% 13 163% Vitamin B6, mg 0.6 RDA 2.1 350% 1.0 167% Folate, µg 200 RDA 215 108% 252 126% Vitamin B-12. µg 1.2 RDA 7.2 600% 4.1 342% Calcium, mg 1000 RDA 761 76% 1667 167% Copper, mg 0.44 RDA 0.9 205% 0.80 182% Phosphorus, mg 500 RDA 872 174% 1229 246% Potassium, mg 3800 AI 1790 47% 2427 64% Magnesium, mg 130 RDA 192 148% 220 169% Manganese, mg 1.5 AI 1.45 97% 1.95 130% Selenium, mcg 30 RDA 44 147% 60 200% Sodium, mg 1200 AI 882 74% 1835 153% Iron, mg 10 RDA 12 120% 8 80% Zinc, mg 5 RDA 11 220% 8 160% Table 11. Subject 4: Nutrient Comparison to Standard
Column Key: Rec = Clinical Recommendation; Standard = Dietary Intake Reference (DRI) that clinical recommendation was based; Calc = Previous RDN calculation; Eq = Clinical Equation; RDA = Recommended Dietary Allowance; AI = Adequate Intake; CF= Commercial Formula nutrient amount; CF%= Commercial Formula percentage of recommendation; HBF= Homemade Blenderized Formula nutrient amount; HBF%= Homemade Blenderized Formula percentage of recommendation
61 Gastrointestinal Symptoms
Each subject presented with 3-5 gastrointestinal symptoms (mean 3.5 per subject).
All subjects experienced some degree of symptom alleviation. Subject 1 had an alleviation of all GI symptoms; Subjects 3 and 4 had an alleviation of 3 symptoms; and
Subject 2 had an alleviation of 2 symptoms. Of total symptoms experienced, 75% resolved and 25% remained. By visit 3, no subjects were experiencing diarrhea, retching, or vomiting. The remaining symptoms of: gas, distention, and constipation were documented to persist into the end of the study. It was also noted that subjects 3 and 4 experienced new GI symptoms (gas and distention) after their transition to HBF (between visit 1 and 2). But overall, there appeared to be a general improvement in gastrointestinal symptoms.
Constipation Diarrhea Retching
V1 V2 V3 Δ V1 V2 V3 Δ V1 V2 V3 Δ
Subject 1 1 0 0 0 1 0 0 0 0 0 0 0
Subject 2 1 1 1 1 0 0 0 0 1 0 0 0
Subject 3 0 0 0 0 1 0 0 0 1 1 0 0
Subject 4 1 1 0 0 0 0 0 0 0 0 0 0
Table 12. Effect of HBF on Individual Gastrointestinal Symptoms after Transition as documented by Caregiver Interview
Column Key: V1 = Visit 1; V2 = Visit 2; V3 = Visit 3; Δ = post intervention. In “Δ” column, 0 = symptom was alleviated or absent; 1 = symptom developed or continued to persist.
62
Vomiting Gas Distention
V1 V2 V3 Δ V1 V2 V3 Δ V1 V2 V3 Δ
Subject 1 0 0 0 0 1 0 0 0 1 0 0 0
Subject 2 1 0 0 0 0 0 0 0 0 0 0 0
Subject 3 1 1 0 0 0 1 1 1 0 0 1 1
Subject 4 1 0 0 0 1 1 1 1 0 1 0 0
Table 13. Effect of HBF on Gastrointestinal Symptoms after Transition (continued) as documented by Caregiver Interview
Column Key: V1 = Visit 1; V2 = Visit 2; V3 = Visit 3; Δ = post intervention. In “Δ” column, 0 = symptom was alleviated or absent; 1 = symptom developed or continued to persist.
Symptoms Alleviated Persistent Symptoms Subject 1 4 0 Subject 2 2 1 Subject 3 3 2 Subject 4 3 1 % Of Total 67% 33% Table 14. Symptom Alleviation after HBF Study
Quality of Life
The PEDsQL Dimension Scores were difficult to assess, due to the high percentage of incomplete questions by parents. Three of the parents answered an average of only 5.3 domains out of the 14. The parent of Subject 4 was the only one to have successfully completed the questionnaire in its entirety. In order to reverse score and
63
linearly transform the questions into meaningful data, 50% of the questions had to be answered. The decision was made not to use the information provided from the PEDsQL.
Parents felt questions were difficult to answer due to their subjectivity and reliance on their child to communicate. Due to the subject’s impaired neurodevelopmental status, they were unable to do so, which created parent frustration. Parents wanted a more objective tool that could capture symptomology without input from their child. The two most commonly answered domains, “blood in bowel movement” and “gas/bloating” were easier for parents to answer because they could visually inspect for blood in stool and abdominal distention. With a nonverbal child, parents did not know whether they were experiencing “stomach pain and hurt”, “stomach discomfort”, or “worry about bowel movements”. From this study, a modified PEDsQL was drafted using objective measures to capture the existence and severity of GI symptoms in children with cognitive or communication impairments.
64 Discussion
Overall Nutritional Adequacy
When examining overall results, it appears that HBF was superior in the provision of the chosen nutrients at the end of the study for Subjects 1 and 2, when compared to their commercial formula prescription at the initial visit. In subject 3, commercial formula was identified as the more nutritionally adequate formula, but only by two nutrients. Lastly, the commercial formula and HBF in subject 4 was nutritionally comparable, with both delivering 20 nutrients according to their clinical recommendations. Based on these results, homemade blenderized formulas at visit 3 were nutritionally comparable to the initial commercial formula prescriptions.
Initial Follow-Up Visit and RDN Intervention
Most homemade blenderized formulas require RDN intervention and monitoring in order to get to the desired results. During the first 3 months on HBF, two of our study subjects saw a decline in nutritional adequacy (1 and 3). Subject 1 was originally receiving 10 nutrients in adequate amounts on commercial formula; however, HBF caused subject 1 to only have 7 nutrients in adequate amounts at visit 2. This may be due to the fact that her HBF in visit 2 was only providing 76% of energy recommendations
65 (642 kcal). Even though the formula may have been more nutrient dense, the volume of the formula was not sufficient enough to demonstrate those values.
RDN intervention allowed the formula to meet energy recommendations by visit 3, through the additions of molasses and a one-ounce equivalent of grains. Fortified grains and molasses may have contributed to the increase in energy, carbohydrate, fiber, iron, and zinc, in the HBF for visit 3. Weight loss was also slowed for subject 1, after RDN intervention.
At the first follow up visit, subject 3 had an even more substantial decrease in nutritional adequacy, from 18 adequate nutrients to only 13. Again, this subject was not consuming enough energy via her HBF recipe. The caregiver was providing 60% of her energy recommendations in the formula. Is it possible that nutrient decreases were largely due to the HBF’s inadequate energy content and volume? Both of the subjects, who saw decreases in nutritional content, also had about a 30-40% decrease in kilocalories from their commercial formula prescription. RDN intervention for subject 3 included adding two 60mL feeds to her daily regimen and table salt. This was likely responsible for the increase in energy, carbohydrates, protein, fat, water, and sodium.
Homemade blenderized formulas were seen to improve the nutritional composition of the formula immediately at visit 2, in two subjects (2 and 4). Both of these subjects were receiving an adequate provision of kilocalories. Subject 2 was receiving 10 nutrients in adequate amounts at visit 2, compared to only 8 on commercial formula. Despite the increase, the RDN still recommended an increase in fluid boluses
66
and that molasses be included in the daily formula preparation. Although, molasses was being added for calories, iron and calcium; these nutrients did not improve by visit 3.
Nutrient improvements may require more than an addition of a single food item. Subject
4 also saw improvements by the first follow up visit. Adequate nutrient delivery increased from 20 to 24 nutrients, while on HBF. RDN intervention focused on increasing her oral intake and tolerance of food.
Homemade Blenderized Formula Nutrient Concerns
There were several nutrients that were consistently low throughout the HBF recipes. These low nutrient levels, if not intervened upon may result in clinical deficiencies or have medical consequences. The nutrients highlighted in this section will include: energy, vitamin D, calcium, sodium, and potassium.
Energy: As mentioned previously the provision of energy was low in half of our study population (n=2). A low energy formula is correlated with a lower provision of other nutrients. It is important to ensure that the formula is meeting the clinical recommendation for energy. It may even be safer to recommend 120-140% of the clinical recommendation for energy to ensure that the subject is being adequately nourished. In our sample population, consuming 120-140% of caloric recommendation did not result in problematic weight gain. Subject 4 gained 0.22 lbs when given 166% of her energy recommendation. It is possible that patients may require higher energy prescriptions while on HBF. Monitoring weight between visits will be a vital task for RDNs. For suggestions to increase energy content in HBF (see Appendix F).
67
Calcium and Vitamin D: Regardless of the formula, whether commercial or homemade, calcium and vitamin D intakes were inadequate. This may be problematic since children with cerebral palsy have deficient bone growth and an increased propensity for non-traumatic fractures.79 Children with moderate to severe CP (GMFCS Level III-V) have low bone mass in both the lumbar spine and lower extremities due to ambulatory ability.79 Therefore, calcium and vitamin D intake need to be properly managed for this high-risk population. For suggestions to increase calcium content in HBF (see Appendix
G). If intake remains inadequate, supplementation may be deemed necessary.
Sodium: Sodium was inadequate in both commercial formula and the initial HBF.
Most of the caregivers were recommended to increase their usage of table salt, which made the HBF formulas adequate in the provision of sodium by visit 3. Table salt was typically needed in the amount of 1 teaspoon per day, which can be simply added into the daily formula recipe.
Potassium: On average, subjects were only consuming 43% of the clinical recommendation for potassium in their HBF formulas. Adequacy ranged from 21% to
64% of the clinical recommendation, and remained inadequate at each study visit. Low potassium levels are associated with cardiac arrhythmias, fatigue, and depression.80
Potassium is important for fluid balance, acid-base balance, nerve impulse conduction, muscle contraction, and for heartbeat regulation.80 For suggestions to increase potassium
content in HBF (see Appendix H). If potassium intake remains inadequate, supplementation may be warranted. 68
Weight
According to the Pediatric Nutrition Handbook published by the American
Academy of Pediatrics, children 2 years to puberty should gain an average of 2-3 kg and grow 5-8 cm per year.81 These guidelines are for typically developing children and our population does not fit this same sta4ndard but even with that consideration, weight loss is not recommended. Per results of this study, weight should be carefully monitored when implementing HBF. Our results were mixed regarding whether HBF feedings can enable pediatric patients to maintain or gain weight appropriate to their individual needs as measured by the CP GMFCS Level 5 – Tube Fed Growth Charts.
In this study, two subjects lost weight (Subjects 1 and 2) causing one to drop below a desirable BMI range. Subject 1 lost 9.2 lbs. over the course of the study. Her original commercial formula prescription was contributing 99% of her daily caloric needs
(925kcal/d). When she was fully transitioned to HBF by visit 2, her calorie intake decreased by 23% (708 kcal/d). The research team recommended that the caregiver of
Subject 1 give an additional serving of grains, and one tablespoon of molasses to the formula to provide 1000 kcal/d. By visit 3, Subject 1 was consuming 127% of her estimated energy needs (1182 kcal/d). Based on the increased provision of energy, it would be reasonable to assume that the subject would gain weight or at least maintain her current body weight between visits 2 and 3; however, she continued to lose an additional
3.7 lbs after the dietary intervention.
The other two subjects (3 and 4) maintained their initial body weight, with a slight gain in Subject 3 (1.76 pounds). Intriguingly, energy delivery was typically much higher 69
with homemade blenderized formulas. The average energy delivery of commercial formula was 98% of clinical recommendations; whereas, HBF at visit 3 was 127% of clinical recommendations. Based on this, we should have seen an increase in weight from visit 2. This indicates that other factors may have been involved.
It is possible that parental error in recall of dietary records occurred. This study relied on documentation of the foods used in HBF recipes and certainly; there was room for error both in documentation and in translation of these recipes for analysis. It is also possible that caloric intake dropped between the initial visit and visit 3 and was sustained for a period of time. Response bias may have occurred, which is the tendency for the person to answer questions untruthfully due to the pressure they believe is exerted on them from the researcher. The child could have also been engaging in more physical therapy or other energy requiring activities. Physical activity was not documented as a part of this study. Anthropometric measurements were also not taken by the same staff member at each visit, adding the potential for variability in measuring. Measurement error for either height or weight could have occurred as this is frequently documented in the literature and in practice.82
Food Variety
Variety is a basic foundation for dietary pattern recommendations. By consuming an increased variety of foods, it is believed that there is a greater variety of nutrients that are consumed and an improvement in the quality of the diet. When evaluating the number
70
of foods used in the blenderized recipe for the enteral feeding, it would then be logical that the higher number of foods used would correlate with the higher levels of nutritional adequacy. This study demonstrates that even though subject 3 and 4 had 11 and 35 foods on average in their recipe, they achieved the highest value for nutritional adequacy, which contradicts this premise. Subject 1 was also able to meet almost half of her nutritional needs with only 8 foods on average in the recipe. Subject 2 had the lowest value for nutritional adequacy and had an average of 21 foods in their recipe. It can perhaps be generalized then that it is the foods that are chosen for the recipe that are important for adequacy, and not necessarily the number of foods.
Specific Nutrient Profiles
Calcium
Calcium in the most abundant mineral found in the human body, and is essential for the formation and metabolism of bone. Over 99 percent of total body calcium is found in the bones and teeth, and thereby providing support to the skeletal structure and function. The remaining calcium is used for mediating muscle contractions, nerve transmissions, intracellular signaling and hormonal secretion.69
Calcium deposition into the bone is an ongoing process through childhood and adolescence, and reaches its maximal accretion during puberty.69 Approximately forty percent of total bone mass is acquired during puberty, when gonadal steroids and growth hormone secretions are maximized. An adequate intake of calcium during this
71
developmental period is crucial because it will determine adult bone mass and be a predictive factor for fracture risk in later life.83
Osteoporosis evaluation and prevention is important for all of our four study subjects with cerebral palsy. Cerebral palsy is the most prevalent childhood condition associated with osteoporosis, since bone density is significantly decreased with CP.84
Malnutrition, immobility, sex steroid deficiency and other factors have been found to interrupt bone mineral accrual and commence early bone loss in children with CP.84
Therefore, improving nutritional status, regulating hormonal imbalances, managing medications and engaging in weight bearing activities should be routine practice in the medical management of this population.84 The Recommended Dietary Allowances
(RDA) and Estimated Average Requirement (EAR) for calcium is as listed in Table 23.
Dietary Reference Intake Calcium Recommendations
Age RDA EAR
1-3 years 700mg 500mg
4-8 years 1,000mg 800mg
Females, 9-13 years 1,300mg 1,100mg
Females, 14-18 years 1,300mg 1,100mg
Table 15. National Institutes of Health: Dietary Reference Intake Calcium
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In the United States, an estimated 72 percent of calcium comes from milk, cheese, yogurt, and from foods to which dairy products have been added (i.e. pizza, lasagna, desserts). The United States Department of Agriculture (USDA) estimated in 2010, that only a small proportion of calcium is derived from other sources: vegetables (7%), grains
(5%), legumes (4%), fruit (3%), meat (3%), eggs (2%), and miscellaneous foods (3%).69
The fortification of calcium is also another common practice within the American food market (i.e. the fortification of orange juice).
73
Figure 7. Calcium (mg) Intake Study Visits 1-3
74 Commercial formula was meeting 100% of the clinical recommendations in
Subject 3. The other subjects were not receiving their recommended levels of calcium from commercial formula. Commercial formula met 88%, 59%, and 76% of calcium recommendations for subject 1, 2 and 4.
By visit 2, calcium intake increased in Subjects 2 and 4, while decreasing in the other two subjects. Only subject 4 was receiving 100% of her recommendation. In visit 3, again only Subject 4 was the only subject to have an adequate intake. Both commercial formula and homemade blenderized formula were only supporting the calcium needs of one subject; thus necessitating supplemental calcium.
Calcium Rich Foods from Dietary Records Visit 2 Visit 3 Subject 1 Soy milk, fortified* Soy milk, fortified* Subject 2 Fortified Instant Oatmeal, whole Fortified Instant Oatmeal, milk, cream of wheat*, yogurt, whole milk, cream of wheat*, honey nut chex cereal™ yogurt, Greek yogurt Subject 3 2% milk*, cheerios™ 2% milk*, cheerios™* Subject 4 Kellogg Nutrigrain bar®*, 1% Greek yogurt*, wheat bread, milk, spinach, American cheese*, 2% milk pudding*, Greek yogurt, Kellogg frozen waffle®, cheerios™*
Table 16. Calcium Rich Foods from Dietary Records
Foods were listed if considered excellent sources (>20% of DRI) or good sources (10-19% of DRI) of the nutrient. Rules were applied based on the U.S. Food and Drug Administration: Food Labeling Guide. An asterisk (*) denotes the highest sources of that nutrient in the recipe.
75 Foods that had the largest contribution to calcium intake in the blenderized recipes included: fortified soy milk, instant oatmeal, cream of wheat, milk (1%, 2%, whole), Greek yogurt, regular yogurt, fortified cereal (honey nut Chex™, Cheerios™),
Kellogg waffles®, pudding, spinach, American cheese, wheat bread, and Kellogg nutrigrain bar®. The caregivers for subjects 1 and 3 used the same calcium rich foods in their blenderized formulas for visits 2 and 3. However, the portion sizes of those foods increased by visit 3, contributing to a higher calcium intake. The caregiver for subject 4 actually used fewer foods at the end of the study, but the calcium intake increased. This indicates that again, it may not be the number of foods that results in nutritional adequacy; it is most likely the quality and portion sizes of foods used. The incorporation of milk, soymilk, yogurt, cream of wheat, and fortified cereal had the greatest impact on calcium composition in the HBF recipe.
Vitamin D
Vitamin D promotes calcium absorption in the gut, and maintains adequate serum calcium and phosphate concentrations to enable normal mineralization of bone.69 Vitamin
D also plays a role in cell growth, neuromuscular and immune function, and the reduction of inflammation.69
Similar to calcium, adequate vitamin D is crucial for bone development in children and adolescents. A diminished bone density and tendency to fracture with minimal trauma is common in children and adolescents with cerebral palsy.85 Low bone density, stiff joints, poor balance and seizures are components of the disease that increase
76 fracture risk.85 Henderson, et al (2002) found in a sample of 117 children with CP, osteopenia was found in the femur of 77% of the cohort. Of this sample, fractures had already occurred within 26% of the subjects who were older than 10 years of age.85
The Recommended Dietary Allowances (RDA) for vitamin D is listed in Table 26.
Dietary Reference Intake Vitamin D Recommendation
Age RDA
Females, 1-13 years 15 mcg
Females, 14-18 years 15 mcg
Females, 19-50 years 15 mcg
Table 17. National Institutes of Health: Dietary Reference Intake Vitamin D
In the American diet, the main source of vitamin D comes from fortified products, since very few foods in the American diet contain large amounts of vitamin D. The best source of vitamin D in nature is fatty fish (salmon, tuna, mackerel) and fish liver oils.
Small amounts can be found in beef liver, cheese, egg yolks, and mushrooms. Most of the milk in the United States is fortified with 100 IU of vitamin D per cup.69 Ready to eat breakfast cereals, orange juice, yogurt, and margarine are also other products that are typically fortified with vitamin D.
77
Figure 8. Vitamin D (mcg) Intake Study Visits 1-3
78 Commercial formula was meeting 100% of the clinical recommendations in
Subject 1. The remaining subjects were not receiving their suggested dosages.
Commercial formula met 67%, 71%, and 47% of vitamin D recommendations for subject
2, 3 and 4.
By visit 2, vitamin D intake increased in Subject 3, while decreasing in Subjects 1 and 2. Subject 4 was receiving the same amount of vitamin D as in the initial visit. In visit 3, none of the subjects were consuming their RDA for vitamin D. On average, the subjects were only getting 32% of their clinical recommendation by the final visit, compared to 77% in the initial visit. Both commercial formula and homemade blenderized formulas can benefit from vitamin D supplementation.
Vitamin D Rich Foods from Dietary Records
Visit 2 Visit 3
Subject 1 Soy milk, fortified* Soy milk, fortified* Subject 2 Whole milk*, honey nut Chex Whole milk*, yogurt*, tuna* cereal™ Subject 3 2% milk 2% milk*, Cheerios™ Subject 4 American cheese*, tilapia, __ Cheerios™ Table 18. Vitamin D Rich Food from Dietary Records
Foods were listed if considered excellent sources (>20% of DRI) or good sources (10-19% of DRI) of the nutrient. Rules were applied based on the U.S. Food and Drug Administration: Food Labeling Guide. An asterisk (*) denotes the highest sources of that nutrient in the recipe.
79
Foods that had the largest contribution to vitamin D intake in the homemade blenderized formulas included: milk (soy, whole, 2%), yogurt, fortified cereal, American cheese, and tilapia. Vitamin D intake declined with the introduction of HBF. The caregiver of subject 1 used the same ingredient (soy milk) in the same proportion, which caused the delivery of vitamin D to remain at approximately 5mcg per day, which is only one-third of the clinical recommendation. Vitamin D delivery increased in subject 2 due to the addition of tuna, and more frequent use of yogurt. Although the caregiver in subject 4 used food items containing vitamin D, the portion sizes were not great enough.
This caused a 5 mcg decrease in the daily delivery in vitamin D. At visit 3, subject 4 was only receiving an average of 1.9 mcg per day, which is 12% of the clinical recommendation for vitamin D.
Iron
Iron is needed in the body for numerous highly complex processes that are indispensable to human life. Iron is an essential component of hemoglobin, an erythrocyte protein that shuttles oxygen to the lungs and other tissues. Iron is also a component of myoglobin, a protein that provides oxygen to muscle. Iron is also involved in growth, development, cellular functioning, and synthesis of hormones and connective tissue.86
Iron deficiency anemia is relatively common, especially among women and in people who have a diet low in heme iron.87 Children who receive greater than 16-24 ounces of cow’s milk per day are also at risk, due to the decreased absorption of iron that 80 occurs with a high intake of milk. In this sample population of four female subjects, iron is a concern in regards to both blood losses from menstrual cycles and high intakes of milk as foundation of the blenderized formulas. Only one of our study subjects was old enough to be menstruating and no more than 10 ounces of cow’s milk were used in a recipe, lowering the risk of iron deficiency. However, it is important for RDNs to assess all of the possible factors that can impair iron absorption such as: medications (antacids, or proton pump inhibitors), oxalates, polyphenols and high calcium containing foods when creating HBF recipes. The Recommended Dietary Allowances (RDA) for iron is listed in Table 29.
Dietary Reference Intake Iron Recommendation
Age RDA (non-vegetarian)
1-3 years 7mg
4-8 years 10mg
Females, 9-13 years 8mg
Females, 14-18 years 15mg
Table 19. National Institutes of Health: Dietary Reference Intake Iron
There are two sources of dietary iron: heme iron, which comes from hemoglobin and myoglobin in animal sources, and nonheme iron, which is present in both plant and 81
animal tissues. Heme iron is estimated to contribute to >40% of total absorbed iron, due to its enhanced bioavailability.88 In the American diet, the richest sources of heme iron include: lean meat and seafood. Dietary sources of nonheme iron include nuts, beans, vegetables, and fortified grain products.89 However, about 50% of our dietary iron comes from bread, cereal, and other grain products.70,90 For infants, breast milk is a highly bioavailable source of iron but typically not sufficient enough for the developmental needs of infants over 6 months.90 In the United States, infant formulas are typically fortified with 12 mg of iron per liter.86 A diet high in phytates, polyphenols, and calcium will inhibit iron absorption, whereas ascorbic acid can enhance iron absorption. Ascorbic acid has the ability to reduce ferric to ferrous iron and can overcome the negative effects of iron inhibitors.88
82
Figure 9. Iron (mg) Intake Study Visits 1-3
83 Commercial formula was meeting 100% of the clinical recommendations for iron in Subjects 2, 3 and 4. Subject 1 was not receiving her recommended intake of iron, but was closest with the commercial formula prescription. Commercial formula met 93% of the clinical recommendation for Subject 1.
By visit 2, iron intake increased in Subjects 2 and 4, while decreasing in the other two subjects. In spite of the noted reductions in iron, the same three subjects were receiving adequate intakes of iron (>100%). In visit 3, most of the subjects experienced a decreased in iron intake. In the end, subjects 2 and 3 met their recommended needs.
Subject 4, who had a consistently high intake of iron dropped below her recommendation. Long-term use of HBF could warrant iron supplementation.
Iron Rich Foods from Dietary Records Visit 2 Visit 3 Subject 1 Fortified instant oatmeal, soy milk Fortified instant oatmeal*, soy milk Subject 2 Fortified oatmeal*, cream of wheat*, Fortified oatmeal*, canned Cheerios™*, mixed canned peas, cream of wheat*, vegetables, white bread, canned green mixed canned vegetables beans Subject 3 Cheerios™*, Special K Red Cheerios™*, lunchmeat ham Berries®* Subject 4 Kellogg Nutrigrain bar®*, Baked beans with pork, Pediasure®, pudding, fortified hamburger, macaroni and oatmeal*, spinach, hamburger, Rice cheese, spaghetti noodles, Krispies cereal®*, Cheerios™*, fortified instant oatmeal* frozen waffle*, wheat bread
Table 20. Iron Rich Foods from Dietary Records
84
Foods that had the most substantial contribution to iron intake included: fortified instant oatmeal, cream of wheat, fortified cereals, waffles, and Kellogg Nutrigrain bar®.
The caregiver for subject 1 used more fortified oatmeal in her recipes for visit 3, which increased iron content approximately 3.5 mg per day. Subjects 2 and 3 both met their clinical recommendations in visits 2 and 3. Subject 2 only had three ingredients that were good sources of iron but they were used in adequate proportions. Subject 3 had seven ingredients, that when used in combination, resulted in a high iron composition. Subject 4 had four excellent sources of iron in visit 2 which resulted in 217% of her clinical recommendation for iron. Despite all of the iron containing ingredients in visit 3, subject
4 only had one excellent source of iron, which dropped her delivery approximately 13 mg per day from visit 2 to visit 3.
Magnesium
Magnesium is a cofactor in more than 300 enzyme systems that regulate biochemical reactions in the body, and is required for energy production, oxidative phosphorylation and glycolysis. Magnesium is also a structural component in bone, and is a requisite for RNA/DNA synthesis. Lastly, magnesium plays a role in the active transport of calcium and potassium ions, which is important for nerve impulse conduction, muscle contraction and heart rhythm.72
Intriguingly, there have been numerous large clinical studies that have evaluated the evidence regarding magnesium sulfate on neuroprotection. Cerebral palsy is caused by damage to the developing fetal or infant brain. Magnesium sulfate given prior to
85
delivery is hypothesized to reduce the risk of CP by stabilizing vasculature and reducing hypoxic effects.91 Rouse and colleagues gave 2000 women either magnesium sulfate or a placebo and followed their children for 2 years. Although the survival rates were similar in both groups, the incidence of moderate-severe CP was lower in the group with supplemental magnesium sulfate.92 Therefore, magnesium may play a protective role against CP in utero; however, scientific evidence is conflicting. The Recommended
Dietary Allowances (RDA) for magnesium is listed in Table 32.
Dietary Reference Intake Magnesium Recommendation
Age RDA
1-3 years 80mg
4-8 years 130mg
Females, 9-13 years 240mg
Females, 14-18 years 360mg
Table 21. National Institutes of Health: Dietary Reference Intake Magnesium
Even though magnesium plays a physiologic role in the body, and is proven for potential health benefits, surveys indicate that dietary intake of magnesium is inadequate in the U.S. population.93 According to the National Institutes of Health, magnesium is
86
widely distributed in plant foods, animal foods and beverages. Foods that contain dietary fiber generally provide magnesium. Good sources include but are not limited to: green leafy vegetables, spinach, legumes, nuts, seeds, and whole grains. During processing, magnesium is added to some breakfast cereals and other fortified food items.
87
Figure 10. Magnesium (mg) Intake Study Visits 1-3
88 At the initial visit, two subjects were below 100% of their clinical recommendations for magnesium. The average magnesium intake while on commercial formula was 73% of suggested needs. Commercial formulas were meeting 46%, 46%,
154% and 148% of magnesium needs in subjects 1-4, respectively.
By visit 2, magnesium intake increased in three subjects, with the exception of subject 3. Magnesium intake increased on average by 69mg from the initial visit to visit
2. Despite the increase in magnesium, only two subjects (subjects 3 and 4) were meeting
>100% of her clinical recommendations. These were the same subjects who met their needs in the initial visit.
In visit 3, magnesium intake was still increasing in most of the subjects; however, the same two subjects (3 & 4) from the initial and second visit, were the only ones with adequate magnesium intakes. Overall, the commercial formula was comparable to homemade blenderized formula, yet the HBF was closer to meeting the clinical recommendations.
89
Magnesium Rich Foods from Dietary Records Visit 2 Visit 3 Subject 1 Instant oatmeal, soy milk* Soy milk*, yams, instant oatmeal*, molasses Subject 2 Instant oatmeal*, cream of wheat, Instant oatmeal*, banana, banana, yogurt, Cheerios™, mixed yogurt, whole milk canned vegetables, whole milk Subject 3 Cheerios™*, 2% milk*, Gerber Cheerios™*, 2% milk*, Garden Vegetables®, Gerber peas® Gerber Mixed Vegetables®, Gerber Sweet Potatoes and Corn®, avocado* Subject 4 Kellogg Nutrigrain bar®*, Greek yogurt, peanut butter, Pediasure®, Greek yogurt, pudding, baked beans with pork, instant oatmeal*, spinach*, wheat hamburger, macaroni and bread*, peanut butter*, Cheerios™*, cheese, spaghetti, instant tilapia, brown rice oatmeal* Table 22. Magnesium Rich Food from Dietary Records
Foods were listed if considered excellent sources (>20% of DRI) or good sources (10-19% of DRI) of the nutrient. Rules were applied based on the U.S. Food and Drug Administration: Food Labeling Guide. An asterisk (*) denotes the highest sources of that nutrient in the recipe.
Foods that had the most substantial contribution to magnesium intake included: fortified instant oatmeal, cream of wheat, fortified cereals, soy milk, yams, instant oatmeal, molasses, cow’s milk, Gerber pureed vegetables®, avocado, Pediasure®, yogurt, pudding, spinach, wheat bread, peanut butter, tilapia, brown rice, Kellogg
Nutrigrain bar®, baked beans and pork and pasta dishes. The caregiver for subject 1 used more sources of magnesium in visit 3, which resulted in a 161mg increase in magnesium from visit 2. The increase in fortified oatmeal and addition of yam and molasses caused magnesium content to almost double between visits for subject 1. Subject 2 only had one 90
excellent source of magnesium per recipe, which caused her to fall below her clinical recommendation; however, her magnesium intake remained stable between visits and did not decline. Subject 3 had 2-3 excellent sources of magnesium per recipe and had an adequate intake of magnesium. Lastly, subject 4 had six excellent sources of magnesium in visit 2, which allowed her to meet 336% of her clinical recommendations. Subject 4 had a decrease in magnesium intake despite the fact that her caregiver used 7 ingredients containing good levels of magnesium. Only one of these ingredients was considered to be excellent sources, which decreased her intake to 169% of her clinical recommendations.
Sodium
Sodium is critical for nerve impulse transmission, muscle contraction, heart function, and for the transport of nutrients and metabolites in and out of cells. Sodium is also important for maintaining fluid volume outside of cells.94
Most individuals consume much higher amounts of sodium than required with the average intake being > 6-8 grams/day.95 However, children with cerebral palsy often have lower electrolyte intakes than healthy children. It is unknown if the lower nutrient intakes are adequate to meet their dietary needs. 96 McGowan, et al. 2012, studied sodium, potassium, phosphate and fluid status in tube-fed, non-ambulatory children with CP and found that sodium deficiencies were prevalent among this population. These study results also found that the provision of sodium was low in commercial formula intake. Sodium intake ranged from 328 mg to 882 mg in commercial formula prescriptions. The National
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Institutes of Health base their sodium recommendations from an adequate intake level as listed in Table 35.
Dietary Reference Intake Sodium Recommendation
Age Adequate Intake (AI)
1-3 years 1000mg
4-8 years 1200mg
Females, 9-13 years 1500mg
Females, 14-18 years 1500mg
Table 23. National Institutes of Health: Dietary Reference Intake Sodium
The Centers for Disease Control and Prevention (CDC) published a document in
2016, suggesting that more than 40% of our daily sodium intake comes from only 10 types of food. The top ten sources of sodium in the American diet were listed as: breads, cold cuts, pizza, poultry, soups, sandwiches, cheese, pasta dishes, meat dishes, and snacks.97 More than 75% of sodium that Americans eat, comes from restaurant, prepackaged and processed foods. Only 5% of sodium is added during home cooking, 6% at the table, and the remaining 12% from naturally occurring sodium in foods.97
92
Figure 11. Sodium (mg) Intake Study Visits 1-3
93 At the initial visit, all four subjects were below their clinical recommendations for sodium. The average sodium intake while on commercial formula was 42% of Adequate
Intake (AI). Commercial formulas were meeting only 36%, 22%, 37%, and 74% of sodium requirements in subjects 1-4, respectively.
By visit 2, sodium intake increased in all subjects, with the exception of subject 1.
Sodium intake increased on average by 518 mg from the initial visit to visit 2. Despite the increase in sodium, only subject 4 was meeting >100% of her clinical recommendations.
In visit 3, subjects 1, 3, and 4 were now receiving adequate amounts of sodium through their formula. The average intake increased to 156%, representing a 114% overall increase of sodium intake. Homemade blenderized formulas clearly had an impact on the participant’s sodium levels. With the high occurrence of vomiting and diarrhea within this population, sodium should be a nutrient of concern in commercial formula fed patients. In this sample, HBF was superior in the provision of sodium.
94
Sodium Rich Foods from Dietary Records Visit 2 Visit 3 Subject 1 Table salt, soy milk Table salt*, soymilk Subject 2 Instant oatmeal, canned carrots, baked Whole milk, canned peas, beans with franks, table salt*, canned table salt, cream of wheat, mixed vegetables*, taco seasoning, canned mixed vegetables, canned green beans*, whole milk canned tuna, canned carrots
Subject 3 Cheerios™, turkey lunchmeat* Cheerios™*, 2% milk, chicken lunchmeat*, table salt*, ham lunchmeat* Subject 4 Kellogg Nutrigrain bar®, breaded Greek yogurt, hotdog*, chicken patty*, pudding, table salt*, baked beans with pork*, American cheese*, frozen waffle*, table salt*, macaroni and wheat bread, peanut butter, cheese*, spaghetti noodles Cheerios™*, turkey lunchmeat* (cooked in salt water), instant oatmeal, pudding* Table 24. Sodium Rich Foods from Dietary Records
Foods were listed if considered excellent sources (>20% of DRI) or good sources (10-19% of DRI) of the nutrient. Rules were applied based on the U.S. Food and Drug Administration: Food Labeling Guide. An asterisk (*) denotes the highest sources of that nutrient in the recipe.
Foods that had the most substantial contribution to sodium intake included: table salt, milk (soy and cow’s), grains (instant oatmeal, cream of wheat, wheat bread, cereal, pasta, waffle, Kellogg Nutrigrain bar®) canned vegetables/tuna, baked beans with meat, taco seasoning, processed meats, processed cheese, peanut butter, yogurt, and prepackaged pudding. Sodium intake was adequate in all of the HBF recipes that included table salt in amounts that were classified as excellent sources of sodium (>20% of AI).
95
Zinc
Zinc is required for the catalytic activity of approximately 100 enzymes, and it plays a role in immune system function, protein synthesis, wound healing, DNA synthesis, and cell division. Zinc also supports normal development during critical periods of growth and is necessary for proper taste and smell. 98
Young children and adolescents are at a greater risk for zinc deficiency due to the increased zinc requirements during growth.99 The physiological requirements for zinc peak during adolescence at the time of the pubertal growth spurt, which generally occurs in girls between 10-15 years and in boys 12-15 years. 99 The Recommended Dietary
Allowance (RDA) for zinc is listed in Table 38.
Dietary Reference Intake Zinc Recommendation
Age RDA
1-3 years 3mg
4-8 years 5mg
Females, 9-13 years 8mg
Females, 14-18 years 9mg
Table 25. National Institutes of Health: Dietary Reference Intake Zinc
96
A wide variety of foods contain zinc. In the American diet, typical sources of zinc include: oysters, red meat, poultry, beans, nuts, seafood, fortified breakfast cereals, and diary products. Similar to iron, zinc is best absorbed from animal sources due to its enhanced bioavailability. Phytates, a principle storage form of phosphorus in plant tissues, tends to bind to zinc and inhibit its absorption. Thus, causing grain and plant based foods to be lower sources of zinc.
97
Figure 12. Zinc (mg) Intake Study Visits 1-3
98 Commercial formula was meeting >100% of the clinical recommendations for zinc in Subjects 1, 3 and 4. Subject 2 was receiving 88% of her recommended zinc intake, while on commercial formula.
By visit 2, zinc intake decreased in most of the subjects, with the exception of subject 2. The biggest decline in zinc was a 5mg decrease in subject 1. At this stage, three subjects (2-4) were still receiving adequate intakes of zinc (>100%).
In visit 3, only subjects 3 and 4 were meeting their clinical recommendations.
Interestingly, subject 1 had serum values drawn after the completion of the study and was found to need supplemental zinc. Subject 1’s HBF provided 47% and 67% of her clinical recommendations at visit 2 and 3. Although, other factors could have precipitated these low serum levels, her dietary zinc intake was consistently low on homemade blenderized formula. Results from this sample, indicate that commercial formula is superior in the provision of zinc when compared to these HBF recipes.
Due to the multitude of basic biochemical functions of zinc in human cells, there is a broad range of physiological signs of zinc deficiency. Prolonged zinc deficiency can lead to growth retardation, loss of appetite, and impaired immune function. Zinc deficiency can also cause hair loss, diarrhea, weight loss, delayed wound healing, taste abnormalities, and mental lethargy.100 Based on this information, one can speculate that her low zinc intake played a role in her weight loss, along with an inadequate caloric delivery at visit 2.
99
Zinc Rich Foods from Dietary Records Visit 2 Visit 3 Subject 1 Oatmeal, soy milk, chicken* Oatmeal*, soy milk
Subject 2 Oatmeal, Greek yogurt, baked beans Oatmeal*, yogurt, whole with franks, yogurt, cheerios™*, milk, canned peas, pork chicken, hamburger, whole milk chops Subject 3 Cheerios*, 2% milk* Cheerios*, 2% milk*, chicken lunchmeat, avocado, ham lunchmeat* Subject 4 Kellogg Nutrigrain bar®*, Greek yogurt, hotdog*, Pediasure®, breaded chicken patty, baked beans with pork*, oatmeal, hamburger*, wheat bread*, hamburger*, macaroni peanut butter, Cheerios™*, American cheese, spaghetti noodles, cheese* oatmeal Table 26. Zinc Rich Foods from Dietary Records
Foods were listed if considered excellent sources (>20% of DRI) or good sources (10-19% of DRI) of the nutrient. Rules were applied based on the U.S. Food and Drug Administration: Food Labeling Guide. An asterisk (*) denotes the highest sources of that nutrient in the recipe.
Foods that had the most substantial contribution to zinc intake included: oatmeal, soymilk, chicken, red meat (pork, hamburger, hotdog, lunchmeat), yogurt (Greek and regular), cream of wheat, cow’s milk, fortified cereal (cheerios™), wheat bread, canned peas, American cheese, avocado, noodles, peanut butter, Pediasure®, and Kellogg
Nutrigrain bar®. Subjects 1 and 2 only had one excellent source of zinc her study visit, which may have caused them to have lower intakes compared to subjects 3 and 4, who had multiple excellent sources of zinc per visit.
100
GI Symptoms
The use of HBF resulted in the reduction of gastrointestinal symptoms. One Subject 1 had an alleviation of all GI symptoms; Subjects 3 and 4 had an alleviation of 3 symptoms; and Subject 2 had an alleviation of 2 symptoms. Of total symptoms experienced, 75% resolved and 25% remained. No subjects were experiencing diarrhea, retching or vomiting by visit 3. Gas, distention, and constipation were documented to have persisted into the end of the study.
Research also needs to be conducted on the physiological mechanisms behind the gastrointestinal symptom improvement with HBF. Hurt et al. 2015 found that in his sample of 30 adult patients, 83.3% reported that they did not experience any symptoms such as nausea, vomiting, fever, or diarrhea while using HBF. A comparison of patients using HBF and commercial formula demonstrated that there were fewer reported overall symptoms while using HBF.101 These results are consistent with what was found in our study. It has been hypothesized that blenderized gastrostomy feeding may improve gagging/retching and lead to a decrease in dumping syndrome due to slower gastric emptying because of the higher viscosity of the feeding.2 Another hypothesis was that
HBF stimulated a hormonal response that favorably affected GI motility compared with commercial formula. Our research team also speculated that GI symptom alleviation could be due to changes within the microbiota or HBF may have potential anti- inflammatory properties. Yet, the true mechanism behind GI symptom improvement is still unknown at this time.
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PEDsQL Modified Questionnaire
In response to parental frustration, a modified PedsQL was developed at the
Midwestern Children’s Hospital, using more objective measures to allow for easier parental response. Although the tool is not validated at this time, it may give caregivers a chance to present information that would have otherwise been unreported in the original
PedsQL (see Appendix I). The modified questionnaire may be used in the complex feeding clinic to give dietitians more data on the patient’s current health status.
Limitations
The small sample size (n=4) prevented statistical analysis of the data, as statistical tests require a larger sample size to ensure a representative distribution of the population.
Results were primarily based on individual assessment within the data sets per child case study. Although results looked promising, the results of this study cannot be generalized to a wider population without further research.
This retrospective study depended heavily on self-reported data, which can contain several sources of potential bias: (1) selective memory [remembering or not remembering events that occurred in the past], (2) telescoping [unintentionally recalling events that occurred at another time], (3) attribution [attributing positive outcomes to one’s own ability but attributing negative outcomes to external forces], and (4) exaggeration [embellishing events as more significant that what would be suggested by data].
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Threats to internal validity may have included: history, and maturation. The threat of history refers to other external factors that could influence testing of the subject over a period of time (i.e. patients may have experienced medication changes throughout the course of the study which may have caused or alleviated some gastrointestinal symptoms). Maturation would be another threat, defined as any physical or mental change that may occur naturally over time that would affect the dependent variable (i.e. menstruation on iron status).
When entering dietary records into the nutrient analysis software, some information was found to be missing. One parent used a product called “Love Child” in her HBF recipe for visit 3. Since, “Love Child” was not found in the food registry for the software, a manual entry of individual nutrients was required. However, the website for the product only contained a basic nutrition label which lacked detail about nutrients. A phone call was made to the company to inquire about more detailed nutrient information, but the CEO was not able to provide further information. Therefore, it is possible that nutrient amounts for the child could be higher than what was reported in visit 3. Also, the caregiver for Subject 4 did not document details for what her daughter was consuming at school. For example, it was reported that Subject 4 had a “breakfast pizza” for breakfast at school, but the contents on that pizza were not described or known to mom. For nutrient analysis, a generic breakfast pizza had to be selected for her recall.
Lastly, the PEDsQL was dependent on both patient and caregiver input which, may have prevented researchers from identifying changes in domains. Patients were
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unable to appropriately answer questions that were encompassed in the testing tool. Lack of verbal communication from the participant, in combination with parent frustration resulted in a poor response rates. Questionnaires could not be used for their intended purpose.
Need for Future Study
The lack of existing literature on homemade blenderized formula makes it difficult for medical practitioners and registered dietitians to make recommendations regarding HBF. Larger studies spanning across multiple centers are needed to verify study results. Clinical biomarkers should be obtained to further evaluate nutritional status of the patients. Clinical biomarkers would also be valuable to determine if nutritional inadequacies are still possible in HBF with a multivitamin supplement. If not, then some of the fear surrounding the implementation of the diet can be reduced. Prospective study designs are also needed to follow patients over time and track their clinical outcomes.
Studies assessing homemade blenderized formulas for bacterial contamination have only been completed in other countries (Iran, Saudi Arabia, Brazil);59,102–104 therefore we cannot generalize the results to the American population with our current food systems. It would be beneficial for a study to be conducted on HBF bacterial contamination in the United States, so professionals can educate their patients/clients about the potential risks. Without further data on bacterial contamination and nutritional adequacy, we, as Registered Dietitians, may become legally responsible for the potential harm of homemade blenderized formulas that are not stored or designed adequately.
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Lastly future studies need to address the issue of recipe monitoring in rural hospital settings, or facilities that do not have the specialized computer software to analyze the nutrient content of the HBF formulas. For this study, we had access to the
Nutrition Data System for Research (NDSR), which allowed close monitoring of the
HBF recipes and the ability to make adjustments accordingly. Close monitoring is fundamental in order to prevent nutrient deficiency and other legal ramifications.
However, not all healthcare settings have access to such software. Research needs to establish what other systems can be used to ensure the nutritional adequacy and safety of
HBF in our patients.
105 Chapter 5: Use of Homemade Blenderized Formula in Gastrostomy Tube Dependent Pediatric Patients with Feeding Intolerance: A Retrospective Analysis
Ashley Bronston, BS, Marcia Nahikian-Nelms, PhD, RDN, Wendelin Burdo-Hartman MD, Colleen Spees, PhD, RDN, Jill Clutter, PhD, RDN, Carol Williams, RDN
Abstract: The use of blenderized foods for tube feedings are becoming more popular, in response to exploring alternative options to commercial formulas1. Such formulations have been documented to improve gastrointestinal symptoms, including gagging and retching.2,3 However, there is limited research to support the safety and efficacy of homemade blenderized formulas (HBF) in regards to nutritional adequacy, weight maintenance, quality of life and gastrointestinal (GI) symptom alleviation.
Methods: This study was a retrospective chart review. Patients were identified from a pilot study conducted in 2014-15. Additional information was obtained for this analysis by review of medical and dietetic records. Data extracted for each patient included demographic characteristics, diagnoses, anthropometric measurements, an initial commercial formula prescription, a dietitian supervised transition plan, 5-day dietary histories of homemade blenderized recipes, and notes derived from the caregiver interviews. Nutritional adequacy was assessed using the Nutrition Data System for
Research (NDSR) to assess formula volume, energy, macronutrients, and micronutrients.4
The nutritional adequacy of each HBF recipe was evaluated by comparing HBF delivery
106 of energy and 27 key nutrients (including fiber) to the participant’s dietary recommendations, based on age and gender. Weight was monitored and compared throughout study visits using the Cerebral Palsy Gross Motor Function Classification
System (CP GMFCS) Level 5-Tube Fed Growth Charts. The presence or absence of gastrointestinal symptoms was documented at each outpatient visit.
Results: Subjects presented with a mean of 3.5 GI symptoms. All subjects reported some degree of symptom alleviation during the intervention and post intervention, 75% of GI symptoms were resolved. The mean weight loss was 2.53 pounds + 4.14. HBF was superior in the provision of nutrients for Subjects 1 and 2. In Subject 3, commercial formula was identified as the more nutritionally adequate formula, but only by two nutrients. Lastly, the commercial formula and HBF in subject 4 was nutritionally comparable, with both delivering 20 nutrients according to their clinical recommendations.
Conclusions: HBF alleviated most GI symptoms for the subjects in this study; especially symptoms related to diarrhea, retching and vomiting. Weight and nutrient intake must be closely monitored for potential variability. Homemade blenderized formulas may be nutritionally comparable to commercial formula prescriptions, but require close monitoring and intervention by a Registered Dietitian Nutritionist (RDN).
Keywords: homemade blenderized formula, enteral nutrition, tube feedings, pediatric enteral nutrition, blenderized formula
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Introduction: Homemade blenderized formulas (HBF) were first introduced in the 12th century, and later again in the 1800’s, but with poor nutritional outcomes.5 Blenderized food given through a tube increased the risk of infection, contributed to tube occlusion, and did not provide nutritional consistency.5 Sterile commercial formulas of known nutrient composition eventually replaced HBF feedings. Despite the fact that commercial formulas are nutritionally complete, symptoms of feeding intolerance, particularly gagging and retching behaviors, have been seen to dramatically decrease when the formula is partially or fully replaced with HBF.2,6 Using whole foods in enteral nutrition is gaining interest in response to commercial formula intolerance. Homemade blenderized formulas utilize whole foods to supplement standard formulas.1 Anecdotal reports from patients and caregivers have claimed that HBF has also allowed for normalization of the feeding process, greater volume tolerance, and has facilitated a transition to oral feeding. Optimal HBF outcomes are noted when patients meet feeding criteria and oversight is provided by a registered dietitian nutritionist (RDN).6 However, it is difficult to make claims about gastrointestinal improvements without supportive research. To date, there are no randomized controlled trials of HBF or large population studies to demonstrate that homemade blenderized formulas are nutritionally adequate, can alleviate GI symptoms, maintain appropriate weight, and/or improve quality of life.
Though positive anecdotal reports do exist on these areas of interest, only one peer- reviewed study with a sample of thirty-three children has found that HBF may decrease gagging and retching behaviors in children with feeding intolerance and post-
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fundoplication surgery.2 More evidence is needed to support the safety and efficacy of homemade blenderized formula in pediatric patients.
Methods: This study was a retrospective chart review. Patients were identified from a pilot study conducted in 2014-15. Additional information was obtained for this analysis by review of medical and dietetic records. Data extracted for each patient included demographic characteristics, diagnoses, anthropometric measurements, an initial commercial formula prescription, a dietitian supervised transition plan, 5-day dietary histories of homemade blenderized recipes, and notes derived from the caregiver interviews.
Sample Population: The study population included a convenience sample of four pediatric patients, who were recruited from clinics at a Midwestern Children’s Hospital.
Subjects met the following criteria: (a) were between the ages of 2 and 18 years, (b) diagnosed with a neurodevelopmental disability, (c) were on enteral feeding via gastrostomy tube > 3 months, and (d) identified with persistent gastrointestinal symptoms. Persistent symptoms were described as having constipation, diarrhea, retching, vomiting, gas, and/or abdominal pain for at least 4 days out of the week for minimum of one month.3 Caregivers were required to have sufficient literacy and fluency in English to understand the intervention and be capable of completing questionnaires.
Participants were included if food secure, as identified by the Food Insecurity Screen, a two-question survey validated for use in identifying families at risk for food insecurity.
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Patients were not eligible if diagnosed with either short gut syndrome or myelomeningocele, due to the condition’s extreme impact on GI function. Those who were identified as food insecure, or received commercial formula for more than 7 days after the HBF transition were also excluded.
Data Analysis: Diet histories were analyzed using the Nutrition Data System for
Research (NDSR) to assess formula volume, energy, macronutrients, and micronutrients.4
The nutritional adequacy of each HBF recipe was evaluated by comparing HBF delivery of energy and 27 key nutrients (including fiber) to the participant’s dietary recommendations, based on age and gender. The majority of the clinical recommendations were based on the nutrient’s Recommended Dietary Allowance (RDA), but Adequate Intake (AI) was used when an RDA value was not established for that particular nutrient. HBF nutrient delivery was also compared to the commercial formula prescription to assess whether the two formulas were nutritionally comparable. Weight was assessed using the appropriate growth charts. In this case, the Cerebral Palsy Gross
Motor Function Classification System (GMFCS) – Level V charts were used. The presence or absence of gastrointestinal symptoms was documented at each outpatient visit. Symptoms of diarrhea, constipation, gas, retching, vomiting, and distension were compared among visits.
Results: All four female study subjects had ages at the time of completion ranging from
5.3 to 16.5 years (median 6.6 years). The primary diagnoses are summarized in Table 1.
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All subjects were gastrostomy tube dependent for their nutritional needs. Subject four was able to ingest food by mouth; however, typical intakes were less than 4 oz. per day and were not considered sufficient for growth and nourishment. All subjects were on
Miralax and/or Senokot to treat frequently occurring episodes of constipation.
Nutritional Adequacy: Subjects returned for their second outpatient visit after they were fully transitioned off of their commercial formula prescriptions to an individualized full strength HBF.
Subject 1: At visit 2, Subject 1 was only receiving 7 nutrients in adequate amounts while on HBF. Twenty nutrients were found to be below the established threshold for nutritional adequacy. This was a 14% reduction in the provision of adequate nutrients from commercial formula. Dietary intervention was necessary at this stage to prevent further decline in adequacy and to maximize the nutrient density of the HBF recipe. An additional one-ounce equivalent of grains and one tablespoon of molasses was recommended to increase caloric intake. At visit 3, the participant had a notable increase
(22%) in the delivery of adequate nutrients from visit 2. Adequate nutrient provision increased from 7 nutrients in visit 2, to 13 nutrients in visit 3. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that the HBF was slightly superior in regards to nutritional adequacy, by three nutrients.
With RDN intervention, the two formulas were then closely comparable.
Subject 2: When subject 2 returned on HBF for study visit 2, the recipe was providing 10 nutrients in adequate amounts. Seventeen nutrients were found to be below
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the established threshold for nutritional adequacy. This was a 7% increase in the provision of adequate nutrients from the commercial formula prescription. Dietary intervention focused on increasing fluid delivery through bolus flushes of water in order to meet estimated fluid needs, and molasses was added as a source of energy, calcium, and iron. At visit 3, the nutrient delivery remained stable. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that the
HBF was actually superior in regards to nutritional adequacy, by two nutrients.
Subject 3: When the subject returned on HBF for study Visit 2, the recipe was providing 17 nutrients in adequate amounts. Ten nutrients were found to be below our established threshold for nutritional adequacy. This represents a 19% reduction in the provision of adequate nutrients from the commercial formula prescription. Dietary intervention was necessary at this stage to prevent further decline in adequacy and to improve the HBF recipe. At this time, subject 3 was tolerating three HBF bolus feeds of
120mL, but was losing weight. Therefore, two additional feeds of 60 mL were added as into her daily regimen to meet energy requirements. Daily table salt (1/2-1 tsp) was also recommended to increase the sodium content in her HBF. At visit 3, the participant had an increase in the delivery of adequate nutrients from visit 2. Adequate nutrient provision increased from 13 nutrients in visit 2, to 16 nutrients in visit 3. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that the commercial formula was higher in nutritional adequacy, by two nutrients.
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Subject 4: When the subject returned on HBF for study Visit 2, the recipe was providing 24 nutrients in adequate amounts. Only 3 nutrients were found to be below the established threshold for nutritional adequacy. This was a 15% increase in the provision of adequate nutrients from the commercial formula prescription. Dietary intervention involved increasing oral intake of food to 425-525 kilocalories/day. At visit 3, the participant had a decrease in the delivery of adequate nutrients from visit 2. Adequate nutrient provision decreased from 24 nutrients in visit 2, to 20 nutrients in visit 3. When comparing the nutrient content of the commercial formula to the modified HBF in visit 3, it was found that both formulas were nutritionally comparable for Subject 4.
Weight: Mean weight loss was 2.53 pounds + 4.14. The most significant loss was seen in
Subject 1, who lost 9.24 pounds over a six-month period. Her body mass index (BMI) dropped from a normal range between the 50-75%tile (based on the GMFCS Level 5 –
CP female growth charts) to below the <50%tile. Subject 2 was also documented to have lost weight (2.42 pounds). Although the decreased weights were concerning to the research staff, it was difficult to quantify what was considered to be clinically significant in this population. The other two subjects maintained their initial body weight, with a slight gain in Subject 3 (1.76 pounds).
Gastrointestinal Symptoms: Each subject presented with 3-5 gastrointestinal symptoms
(mean 3.5 per subject). All subjects experienced some degree of symptom alleviation. 113
Subject 1 had an alleviation of all GI symptoms; Subjects 3 and 4 had an alleviation of 3 symptoms; and Subject 2 had an alleviation of 2 symptoms. Of total symptoms experienced, 75% resolved and 25% remained. By visit 3, no subjects were experiencing diarrhea, retching, or vomiting.
Discussion: Most homemade blenderized formulas require RDN intervention and monitoring in order to achieve consistent nutritional adequacy. There were several nutrients that were consistently low throughout the HBF recipes for all four of these subjects. These low nutrient levels, if not intervened upon may result in clinical deficiencies or have medical consequences. Nutrients that were consistently low included: energy, vitamin D, calcium, sodium and potassium.
In this study, a low energy HBF formula was correlated with a lower provision of nutrients. It is important to ensure that HBF formulas are meeting the clinical recommendations for energy. It may even be safer to recommend 120-140% of the clinical recommendation for energy to ensure that the subject is being adequately nourished. In our sample population, consuming 120-140% of caloric recommendation did not result in problematic weight gain. Subject 4 gained 0.22 lbs when given 166% of her energy recommendation. It is possible that patients may require higher energy prescriptions while on HBF. Monitoring weight between visits will be a vital task for
RDNs.
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Regardless of the formula, whether commercial or homemade, calcium and vitamin D intakes were inadequate in our sample population. This may be problematic since children with cerebral palsy have deficient bone growth and an increased propensity for non-traumatic fractures.79 Children with moderate to severe CP (GMFCS Level III-V) have low bone mass in both the lumbar spine and lower extremities due to ambulatory ability.79 Therefore, calcium and vitamin D intake need to be properly managed for this high-risk population. Additional supplementation may be warranted with enteral formulas.
Sodium was inadequate in both commercial formula and the initial HBF. Most of the caregivers were recommended to increase their usage of table salt, which made the
HBF formulas adequate in the provision of sodium by visit 3. Table salt was typically needed in the amount of 1 teaspoon per day for our pediatric patients.
On average, subjects were only consuming 43% of the clinical recommendation for potassium in their HBF formulas. Adequacy ranged from 21% to 64% of the clinical recommendation, and remained inadequate at each study visit. Potassium is important for fluid balance, acid-base balance, nerve impulse conduction, muscle contraction, and for heartbeat regulation. Potassium levels need to be closely monitored in homemade blenderized formulas to prevent potential clinical deficiencies.
Again, the use of HBF requires a highly experienced dietitian to be able to create the individualized diet and make modifications over time. The nutrient content of HBF can vary widely and the caloric content often requires adjustment.56 Variability in the
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recipe preparation should be expected, as this is a common theme documented with homemade blenderized recipes.24,57 It may be beneficial to use a validated nutrient analysis program in combination with professional judgment to promote consistency.
Limitations: Results for this small sample size were primarily based on individual assessment within the data sets per child case study. Although results looked promising, the results of this study cannot be generalized to a wider population without further research. This retrospective study depended heavily on self-reported data, which can contain several sources of potential bias: (1) selective memory, (2) telescoping, (3) attribution, and (4) exaggeration. When entering dietary records into the nutrient analysis software, some information was found to be missing. Several products had to be substituted for nutrient analysis when they were not available in the nutrient database.
Finally, the patients were nonverbal which made it difficult for caregivers to fill out subjective questions on the PEDsQL such as “Worries he/she will have to use the bathroom at school”. Questionnaires could only be examined for trends.
Conclusions: When examining overall results, it appears that HBF was superior in the provision of the chosen nutrients at the end of the study for Subjects 1 and 2, when compared to their commercial formula prescription at the initial visit. In subject 3, commercial formula was identified as the more nutritionally adequate formula, but only by two nutrients. The commercial formula and HBF in subject 4 was nutritionally comparable, with both delivering 20 nutrients according to their clinical
116
recommendations. Based on these results, homemade blenderized formulas at visit 3 were nutritionally comparable to the initial commercial formula prescriptions, but only with close RDN monitoring and appropriate intervention. Weight needs to be monitored closely for potential changes. Homemade blenderized formulas resulted in a reduction of
75% of reported GI symptoms.
Need for Future Study: The lack of existing literature on homemade blenderized formula makes it difficult for medical practitioners and RDNs to make recommendations regarding HBF. Larger studies spanning across multiple centers are needed to verify study results. Clinical biomarkers should be obtained to further evaluate nutritional status of the patients. Clinical biomarkers would also be valuable to determine if nutritional inadequacies are still possible in HBF with a multivitamin supplement. If not, then some of the fear surrounding the implementation of the diet can be reduced. Prospective study designs are also needed to follow patients over time and track their clinical outcomes.
Studies assessing homemade blenderized formulas for bacterial contamination have only been completed in other countries (Iran, Saudi Arabia, Brazil);59,102–104 therefore we cannot generalize the results to the American population with our current food systems. It would be beneficial for a study to be conducted on HBF bacterial contamination in the
United States, so professionals can educate their patients/clients about the potential risks.
Without further data on bacterial contamination and nutritional adequacy, we, as
Registered Dietitians, may become legally responsible for the impending harm of
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homemade blenderized formulas. Lastly, future studies need to address the issue of recipe monitoring in rural hospital settings, or facilities that do not have the specialized computer software to analyze the nutrient content of the HBF formulas. For this study, we had access to the Nutrition Data System for Research (NDSR), which allowed close monitoring of the HBF recipes and the ability to make adjustments accordingly. Close monitoring is fundamental in order to prevent nutrient deficiency and other legal ramifications. However, not all healthcare settings have access to such software. Studies need to establish what other systems can be used to ensure the nutritional adequacy and safety of HBF in our patients.
Author Note This publication was supported by the Nationwide Children’s Hospital Foundation (its contents are solely the responsibility of the authors and do not necessarily represent the official view of the hospital. The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
118 References
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90. John Erdman, Ian Macdonald, Steven Zeisel. Present Knowledge in Nutrition. 10th ed. Washington, D.C.: Wiley-Blackwell
91. Kent A. Magnesium Sulphate and Cerebral Palsy. Rev Obstet Gynecol. 2008;1(4):205-206.
92. Rouse DJ, Hirtz DG, Thom E, et al. A Randomized, Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy. N Engl J Med. 2008;359(9):895- 905.
93. Ford ES, Mokdad AH. Dietary Magnesium Intake in a National Sample of U.S. Adults. J Nutr. 2003;133(9):2879-2882.
94. Munteanu Constantin, Iliuta Alexandru. The role of sodium in the body. Balneo- Res J. 2011;2.
95. A Closer Look at Current Intakes and Recommended Shifts - 2015-2020 Dietary Guidelines - health.gov.
126
96. McGowan JE, Fenton TR, Wade AW, Branton JL, Robertson M. An exploratory study of sodium, potassium, and fluid nutrition status of tube-fed nonambulatory children with severe cerebral palsy. Appl Physiol Nutr Metab Physiol Appliquée Nutr Métabolisme. 2012;37(4):715-723.
97. U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015-2020 Dietary Guidelines for Americans. December 2015.
98. Prasad AS. Zinc: an overview. Nutr Burbank Los Angel Cty Calif. 1995;11(1 Suppl):93-99.
99. Roohani N, Hurrell R, Kelishadi R, Schulin R. Zinc and its importance for human health: An integrative review. J Res Med Sci Off J Isfahan Univ Med Sci. 2013;18(2):144-157.
100. Maret W, Sandstead HH. Zinc requirements and the risks and benefits of zinc supplementation. J Trace Elem Med Biol Organ Soc Miner Trace Elem GMS. 2006;20(1):3-18.
101. Hurt RT, Edakkanambeth Varayil J, Epp LM, et al. Blenderized Tube Feeding Use in Adult Home Enteral Nutrition Patients: A Cross-Sectional Study. Nutr Clin Pract Off Publ Am Soc Parenter Enter Nutr. 2015;30(6):824-829.
102. Mokhalalati JK, Druyan ME, Shott SB, Comer GM. Microbial, nutritional and physical quality of commercial and hospital prepared tube feedings in Saudi Arabia. Saudi Med J. 2004;25(3):331-341.
103. Jalali M, Sabzghabaee AM, Badri SS, Soltani HA, Maracy MR. Bacterial contamination of hospital-prepared enteral tube feeding formulas in Isfahan, Iran. J Res Med Sci Off J Isfahan Univ Med Sci. 2009;14(3):149-156.
104. Borghi R, Dutra Araujo T, Airoldi Vieira RI, de Souza TT, Waitzberg DL. ILSI Task Force on enteral nutrition; estimated composition and costs of blenderized diets. (Spanish). GRUPO Estud ILSI SOBRE Nutr Enter Compos COSTOS ESTIMADOS DIETAS Artes Engl. 2013;28(6):2033-2038.
127
Appendix A: Two-Item Food Security Screen
128 Two Item Food Insecurity Scan
Hager ER, Quigg AM, Black MM, et al. Development and validity of a 2-item screen to identify families at risk for Food Insecurity. Pediatrics. 2010; 26: e26-e32.
1. Within the past 12 months we worried whether our food would run out before we got money to buy more. ______Yes ______No
2. Within the past 12 months the food we bought just didn’t last and we didn’t have money to get more. ______Yes ______No
129 Appendix B: Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module Sample
130
131 132 133 134 135 Appendix C: Cerebral Palsy Gross Motor Function Classification System (CP GMFCS) Level 5- Tube Fed Growth Charts
136 137 138 139 Appendix D: Follow-Up Telephone Log and Script
140 Phone+Log
Study&#: Primary&#: (Relation,+Name) *RA+will+call+weekly+between+visit+1+and+2,+monthly+between+visit+2+and+3.+Check+GI+symptoms+at+each+call.
GI+Tolerance Date Caller Basic&Progress Cons Di Ret Vom Gas Dist
141 Follow&Up/Reminder!Call!Script!
Hello,!may!I!please!speak!to!Mr./Ms.!(caregiver’s!name)?!My!name!is!(RA!name)!and!I!am!calling! you!regarding!(patient’s!name)’s!progress!with!their!transition!to!fully!blenderized!formula.!Is!this!a! convenient!time!to!talk!about!(patient’s!name)’s!feeding?!
I!wanted!to!take!the!time!to!check!in!and!see!how!things!have!been!going!for!you!and!(patient’s! name).!How!has!(child’s!name)!been!tolerating!(his/her)!feedings?!Since!we!last!talked,!would!you!say! that!(pt’s!name)!has!been!experienced!constipation,!diarrhea,!retching,!vomiting,!gas,!or!distention?!Are! there!any!major!obstacles!that!you!have!faced!in!transitioning!to!homemade!blenderized!formula?!Are! there!any!questions!or!concerns!that!you!have!for!me!or!Carol?!!!
A"week"before"next"visit:"I!also!wanted!to!make!sure!to!remind!you!of!your!upcoming! appointment!with!us!on!the!(date!and!time).!To!prepare!for!this!visit,!we!asked!that!you!complete!a!5& day!diet!history!before!coming!in,!recording!what!(child’s!name)!has!consumed!both!through!her!tube!or! oral!feedings.!Do!you!have!the!materials!you!need!to!complete!the!5&day!diet!history?!Do!you!have!any! questions!about!the!5&day!diet!history!and!how!to!measure!and!record!your!child’s!diet?!!
Please!feel!free!to!get!a!hold!of!us!at!Carol’s!number!if!you!have!any!questions!or!concerns.!Her! phone!number!is!614&722&5740.!Thanks!for!your!time!and!have!a!great!day.!
Voice"Message:!Hello!(caregiver’s!name),!my!name!is!(RA!name)!and!I!am!calling!from! Nationwide!Children’s!Hospital!to!follow!up!with!(patient’s!name)’s!progress!in!transitioning!to!a!fully! blenderized!formula.!I!will!make!another!attempt!to!reach!you!this!week!or!the!next.!If!you!have!any! questions!or!concerns!regarding!(patient’s!name)’s!formula,!please!feel!free!to!give!us!a!call!back!at! Carol!Williams’!number,!614&722&5740.!Again,!that!number!is!614&722&5740.!Thank!you!and!have!a!great! day.!
"
IRB 14-00041 Use of homemade blenderized formula in gastrostomy tube dependent pediatric patients with feeding intolerance: a pilot study (7/3/2014) Rev-11/19/2014!
142 Appendix E: Diet History Form (with sample)
143 & $
$ $ & + 7/3/2014 tube. / Comments +
$$$$$$$$$$$ $ $ feeding Staff$use$only $ Entered:_____$date:_____ QA:______$date:_____ Notes of tolerance of Notes
that+is+put+through+ + Eaten Amount Amount
+ Study&ID:&______
$ & anything Water Flushes
Total Offered Volume
Visit#:&______$ document+that+as+well.
+ Used /2014 Volume Volume &
Rev$08/13 Total Total Yield Recipe Recipe
Date:&______
: & yield in fl oz. fl in yield
Diet$History$Form If+your+child+takes+any+food+by+mouth Feeding Please include formula formula include Please and it’s total it’s and
. food Include specific brand names or recipe $
oral oral oral oral oral oral oral oral oral Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube feeding / feeding / feeding / feeding / feeding / feeding / feeding / feeding / feeding / Use of homemade blenderized formula in gastrostomy tube dependent pediatric patients with feeding intolerance: a pilot study pilot a intolerance: feeding with patients pediatric dependent tube gastrostomy in formula blenderized homemade of Use
$$$$$$$$$$ Time
Instructions:++For+each+day,+record+exactly+how+much+formula+and+water+given.++Document+ 00041 '
Meal / / Meal Snack Name:&______& IRB$14
144 & $
$ $ &
+ 7/3/2014
/ Comments
tube. + $$$$$$$$$$$ $ $
feeding Staff$use$only $ Entered:_____$date:_____ QA:______$date:_____ feeding84rate ml/hr 10hrsx intolerance of symptoms no nauseasome signsof someburping Notes of tolerance of Notes
- - - -
cup Eaten Amount Amount that+is+put+through+ 28 fl oz fl 28 oz fl 8 ¼ oz fl 7 +
+ Study&ID:&______
$ fl oz fl fl oz fl oz fl oz fl &
Water Water anything Flushes 4 2 2 2 __
___ 2 fl oz fl fl oz fl oz fl
Total Offered Volume 28 10 oz fl 0 10
Visit#:&__ $ document+that+as+well. +
&
Used Volume Volume cup ____ 24 fl oz fl 24 oz fl 6 oz fl 2 oz fl 4 g) (71 jar 1 g) (113 jar 1 oz 2 Tbsp 2 Tbsp 1 ¼ oz fl 6 oz fl 2
Rev$08/13/2014 Total Total Yield Recipe Recipe oz fl 8 oz fl 8
7/30/2014
Date:&__ &
: yield in fl oz. fl in yield
Diet$History$Form formula in gastrostomy tube dependent pediatric patients with feeding intolerance: a pilot study
If+your+child+takes+any+food+by+mouth
Feeding
Please include formula formula include Please
and it’s total it’s and
. cheerios food Include specific brand names or 1% milk 1% chicken food, baby of jar Small peas strained of jar Small peaches Strained Molasses oil Canola recipe
Pediasure Enteral Formula 1.0 Cal Cal 1.0 Formula Enteral Pediasure fiber with cal 1.0 Formula Enteral Pediasure fiber; w/ formula: Blenderized ------Cereal, cal 1.0 Formula Enteral Pediasure fiber; w/ formula Blenderized ______
oral oral oral oral oral oral oral oral oral Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube feeding / feeding / feeding / feeding / feeding / feeding / feeding / feeding / feeding / Use of homemade blenderized blenderized homemade of Use
–
$$$$$$$$$$ John Smith
Time 9:00 9:00 pm 7:00 am 11:30 am 1:30 pm 5:00 pm Instructions:++For+each+day,+record+exactly+how+much+formula+and+water+given.++Document+ ____ 00041
'
-
Meal / / Meal Snack Name:& & IRB$14 Night feed Lunch Snack Dinner
145 Appendix F: Homemade Blenderized Formula Sources of Energy
146 Food Quantity Calories Avocado ½ medium 160 Condensed milk, sweetened 1 Tbsp 75 Cream cheese 2 Tbsp 101 Almond butter 1 Tbsp 101 Almonds, dry ½ oz 84 Peanut butter 1 Tbsp 100 Sunflower seed butter 1 Tbsp 93 Flax seeds 1 Tbsp 64 Butter 1 Tbsp 102 Canola, Corn, Flax, Safflower, Olive, Sesame, 1 Tbsp 120 Vegetable Oil Cheddar cheese 1.5 oz 171 Cottage cheese 2 cup 432 Milk, evaporated, whole 1 cup 300-400 Quinoa ½ cup 170 Banana, mashed ½ cup 100 Figs, dried ½ cup 185 Dates, chopped ½ cup 126 Cranberries, dried ½ cup 187 Yogurt, whole milk 1 cup 244-260 Ricotta, whole milk ½ cup 214 Milk, whole 1 cup 150 Baked beans, franks ¼ cup 92 Beans, black, garbanzo, kidney, navy, pinto, ¼ cup 50-70 soy Molasses 1 Tbsp 47 Mealtime Notions HBF Handbook 1: Samples of Calculated Energy Sources18
147
Appendix G: Homemade Blenderized Formula Sources of Calcium
148
Food, Standard Amount Calcium (mg) Calories Fortified ready-to-eat cereals, 1oz 236-1043 88-106 Plain yogurt, low fat, 8 oz 452 127 Romano cheese, 1.5 oz 452 165 Swiss cheese, 2 oz 438 190 Soy beverage, fortified, 1 cup 368 98 Evaporated milk, nonfat ½ cup 371 100 Ricotta cheese, part skim, ½ cup 335 170 Eggnog, 1 cup 330 342 Sardines, 3 oz 325 177 American cheese, 2 oz 323 188 Provolone cheese, 1.5 oz 321 150 Mozzarella cheese, 1.5 oz 311 129 Cheddar cheese, 1.5 oz 307 171 Milk (skim,1%,2%), 1 cup 276-306 83-146 Tofu, ½ cup 253 88 Blue cheese, 1.5 oz 225 150 Feta cheese, 1.5 oz 210 113 Pink salmon, canned, 3 oz 181 118 Collards, cooked, ½ cup 178 31 Rhubarb, cooked, ½ cup 174 139 Molasses, blackstrap, 1 Tbsp 172 47 Spinach, cooked, ½ cup 146 30 Soybeans, cooked, ½ cup 130 127 Turnip greens, cooked, ½ cup 124 24 Atlantic perch, cooked, 3 oz 116 103 Mealtime Notions HBF Handbook 2: Samples of Calculated Calcium Sources18
149 Appendix H: Homemade Blenderized Formula Sources of Potassium
150 Food, Standard Amount Potassium (mg) Calories Sweet potato, baked, 1 potato 694 131 Tomato paste, ¼ cup 664 54 Beet greens, cooked, ½ cup 655 19 Potato, baked, flesh, 1 potato 610 145 White beans, canned, ½ cup 595 153 Yogurt, plain, nonfat, 8 oz 579 127 Raisins, seedless, ½ cup 563 225 Tomato puree, ½ cup 549 48 Artichokes, cooked, boiled, ½ medium 531 75 Prune juice, ¾ cup 530 136 Carrot juice, ¾ cup 517 71 Molasses, blackstrap, 1 Tbsp 498 47 Hailbut, cooked, 3 oz 490 119 Soybeans, green, cooked, ½ cup 485 127 Tuna, yellowfin, cooked, 3 oz 484 118 Lima beans, cooked, ½ cup 484 104 Squash, cooked, ½ cup 448 40 Cod, cooked, 3 oz 442 103 Evaporated milk, nonfat, ½ cup 425 100 Banana, 1 medium 422 105 Spinach, cooked, ½ cup 419 21 Tomato juice, ¾ cup 417 31 Tomato sauce, ½ cup 405 39 Peaches, dried, uncooked, ¼ cup 398 96 Prunes, stewed, ½ cup 398 133 Papaya, ½ medium 391 60 Mealtime Notions HBF Handbook 3: Samples of Calculated Potassium Sources18
151 Appendix I: Pediatric Quality of Life Inventory - Modified Questionnaire
152
Gastrointestinal Questionnaire Parental Recall of Symptoms
Patient Name: ______MRN: ______Date of Birth: ______Date: ______
The following questions are used to assess the severity of gastrointestinal intolerance associated with oral and/or tube feedings.
Food Allergies: Check all that apply. Wheat Eggs Dairy Products Peanuts/ Tree Nuts Soy Corn Fish/Shellfish Other ______
Directions
Please allow your healthcare staff to assess items that may be an issue for your child. Tell us how much of a problem each one has been for your child during the past ONE month by circling:
0: Never is a problem 1: Almost never a problem 2: Sometimes a problem 3: Often a problem 4: Almost always a problem
In the past ONE month, how much of a problem has this been for your child?
Trouble Swallowing Never Almost Some- Often Almost Never times Always Is it difficult for your child to chew 0 1 2 3 4 N/A food? Is it difficult for your child to 0 1 2 3 4 N/A swallow foods or liquids? Does chewed up food or liquid 0 1 2 3 4 N/A dribble from your child’s mouth? Does your child experience difficulty 0 1 2 3 4 N/A
153
breathing during meals? Does your child experience 0 1 2 3 4 N/A excessive drooling during mealtimes? Pocket food in cheeks? 0 1 2 3 4 N/A Have sudden episodes of coughing 0 1 2 3 4 N/A or gagging?
*Please mark N/A above if your child receives feeds via gastrostomy or jejunostomy.
Nausea and Vomiting/Retching Never Almost Some- Often Almost Never times Always Does your child experience episodes 0 1 2 3 4 N/A of gagging with vomiting during feeding? Does your child experience episodes 0 1 2 3 4 N/A of gagging without vomiting during feeding?
Heartburn and Reflux Never Almost Some- Often Almost Never times Always Does your child burp a lot with 0 1 2 3 4 N/A feedings? Does your child burp up food or 0 1 2 3 4 N/A liquids within 15 minutes after a meal? If yes, does your child experience pain? Yes or No Does your child experience hiccups 0 1 2 3 4 N/A with feedings?
Gas and Bloating Never Almost Some- Often Almost Never times Always Does your child experience severe 0 1 2 3 4 N/A swelling or bloating of the stomach? Have excess gas and flatulence? 0 1 2 3 4 N/A Stomach makes loud noises? 0 1 2 3 4 N/A
Stomach Never Almost Some- Often Almost Never times Always Does your child experience stomach 0 1 2 3 4 N/A pain that lasts longer than a few minutes when eating? 154
Wakes up in the night with stomach 0 1 2 3 4 N/A pain?
Constipation Never Almost Some- Often Almost Never times Always Experience obvious straining during 0 1 2 3 4 N/A bowel movement? Have stools that are hard, and 0 1 2 3 4 N/A painful to pass? Have incomplete bowel movements 0 1 2 3 4 N/A and stool back ups? Takes a long time for stool to come 0 1 2 3 4 N/A out? Have blood in his/her bowel 0 1 2 3 4 N/A movement? Have mucus (white, yellowish 0 1 2 3 4 N/A stringy material) in his/her bowel movement? Have poop accidents in his/her 0 1 2 3 4 N/A underwear?
Diarrhea Never Almost Some- Often Almost Never times Always Does your child have frequent, loose 0 1 2 3 4 N/A and watery stools?
G-Tube Venting/ Residuals Never Almost Some- Often Almost Never times Always Does your child experience gastric 0 1 2 3 4 N/A residuals? If yes, how much ______mL? Require frequent venting of feeding 0 1 2 3 4 N/A tube?
Sleeping Patterns Never Almost Some- Often Almost Never times Always Does your child have trouble 0 1 2 3 4 N/A sleeping at night? Is restless and moves a lot during 0 1 2 3 4 N/A sleep?
Fatigue Never Almost Some- Often Almost Never times Always 155
Does your child seem tired during 0 1 2 3 4 N/A the daytime? Falls asleep frequently during 0 1 2 3 4 N/A daytime? Falls asleep while involved in 0 1 2 3 4 N/A activities or therapies?
Weight Never Almost Some- Often Almost Never times Always Are you concerned about your 0 1 2 3 4 N/A child’s weight? Are you worried about meeting 0 1 2 3 4 N/A nutritional needs?
Moods/Communication Never Almost Some- Often Almost Never times Always Can your child communicate with 0 1 2 3 4 N/A others through speaking? Is it difficult for your child to 0 1 2 3 4 N/A express hunger? Experience irritability around 0 1 2 3 4 N/A mealtime?
Tell us any other symptoms your child has with feedings that was not addressed in this questionnaire:
Scoring (points):
No Risk: 0-37 Mild Risk/Moderate: 38-111 Severe Risk: >111
156