Safety and Effectiveness of Homemade and Reconstituted Packet Cereal- based Oral Rehydration Solutions: A Randomized Clinical Trial Alan Meyers, MD, MPH*; Amy Sampson, PhD*; Richard Saladino, MD‡; Sujata Dixit, PhD§; William Adams, MD*; and Alejandro Mondolfi, MD‡ ABSTRACT. Objectives. Parents may be deterred tended to take less ORS and total fluids. There were no from obtaining commercial oral rehydration solutions significant differences among the three groups in inci- (ORS) for their young children with acute diarrheal dis- dence of daily vomiting or stooling, duration of diarrhea, ease because of its availability and/or cost, especially if or weight gain. they are poor. We conducted a randomized clinical trial Conclusions. CBORS do not offer a clinically signif- to determine 1) whether low-income parents could safely icant advantage over glucose-based ORS. Homemade mix and administer cereal-based ORS (CBORS) both CBORS represent a treatment option in carefully selected from ingredients commonly found in the home and from cases, but it is not the safest alternative for regular clin- a premixed packet; 2) whether these CBORS were as ical use. Pediatrics 1997;100(5). URL: http://www. effective in maintaining hydration as commercial glu- pediatrics.org/cgi/content/full/100/5/e3; diarrhea, dehy- cose-based ORS; and 3) whether CBORS were more ef- dration, oral rehydration, cereal. fective in reducing severity and duration of illness. Methods. Children 4 to 36 months of age discharged from emergency departments and health centers with ABBREVIATIONS. ORT, oral rehydration therapy; ORS, oral re- acute diarrheal disease were randomized to receive either hydration solutions; CBORS, cereal-based oral rehydration solu- homemade CBORS, reconstituted packet CBORS, or Pe- tions; CI, confidence interval. dialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood cute infectious diarrhea is a common illness for serum sodium at enrollment and at 24 to 48 hours; a in young children worldwide and in the sample of CBORS for sodium concentration; stool for United States, where children average be- pathogen analysis; and daily fluid intake, stool fre- A quency, and weight. tween 1.3 and 2.3 episodes per child per year for the 1 Results. A total of 232 children were enrolled, of first 5 years of life. Each year, approximately 1 of 5 whom 203 (88%) completed the study. Two parents (3%) children ,5 years of age sees a physician for diar- in the homemade CBORS group and one parent (1%) in rhea, and 1.4% are hospitalized, resulting in the packet CBORS group made mixing errors resulting in .200 000 hospital admissions, or 10.6% of all admis- a high sodium concentration (>100 mEq/L); their chil- sions in this age group.1 It has been estimated that dren refused the solution and had normal serum sodium the annual national cost of hospitalization for rota- values. Mean CBORS sodium concentration for the re- virus-associated gastroenteritis was $352 million in mainder of the homemade CBORS group was 60 6 10 1988.2 Some 300 children ,5 years of age die in the mEq/L, and for the packet CBORS group, 54 6 13. Eigh- teen children (11%) had abnormal serum sodium values United States each year because of diarrhea, a rate at presentation, which returned to normal in all groups in that has not declined since 1985. These deaths occur most cases. Three children (4.5%) in the homemade primarily in infants and disproportionately among CBORS group, 4 (6%) in the packet CBORS group, and 1 those who are African-American, premature, and liv- child (1.4%) in the Pedialyte group failed therapy. ing in Southern states and in metropolitan areas.3 Children refused to take homemade CBORS and Oral rehydration therapy (ORT) is safe, effective, packet CBORS (43% and 32%, respectively) more often less invasive, and less expensive than intravenous than Pedialyte (9%), and those in the CBORS groups rehydration for the treatment of diarrheal dehydra- tion, and its use in the home early in the course of From the *Division of General Pediatrics, Boston Medical Center, Boston illness can prevent the development of dehydra- University School of Medicine, Boston, Massachusetts; ‡Division of Emer- tion.4–8 ORT has been promoted in practice guide- gency Medicine, Children’s Hospital, Harvard Medical School, Boston, lines published by the American Academy of Pedi- Massachusetts; and §Department of Maternal and Child Health, Harvard 9,10 School of Public Health, Boston, Massachusetts. atrics (AAP) and the Centers for Disease Control This work was presented, in part, at the Ambulatory Pediatric Association and Prevention.11 However, there are economic bar- Annual Meeting, Washington, DC, May 9, 1996. riers to the use of ORT for low-income families,12 Dr Sampson is currently at the Perinatal Epidemiology Unit, Department of who may have to pay .$6 per liter in their neigh- Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT. borhood pharmacy for commercial oral rehydration Dr Dixit is currently at the Department of Human Nutrition and Dietetics, solutions (ORS). Coverage of commercial ORS varies University of Illinois at Chicago, Chicago, IL. among the state Medicaid programs,13 and one Received for publication Oct 29, 1996; accepted May 21, 1997. fourth of children in low-income families in the Reprint requests to (A.M.) Department of Pediatrics, Boston Medical Center, Boston, MA 02118. United States have no health insurance coverage at 14 PEDIATRICS (ISSN 0031 4005). Copyright © 1997 by the American Acad- all. emy of Pediatrics. A possible approach to this problem is the promo- http://www.pediatrics.org/cgi/content/full/100/5/Downloaded from www.aappublications.org/newse3 PEDIATRICS by guest on October Vol. 2, 100 2021 No. 5 November 1997 1of7 tion by health professionals of ORS prepared from consent, administered a structured questionnaire, and obtained ingredients commonly found in the home, as is done capillary blood for serum sodium assay. 15 Children were assigned to one of three treatment groups using in some programs in poor countries. However, randomization in blocks of nine subjects each. Group 1 received there are concerns that inaccurate measurement of homemade CBORS, prepared by mixing 2 cups of water, 1⁄2 cup of either sugar or salt could produce an ineffective or instant baby rice cereal (Gerber Products Co, Fremont, MI), and 1⁄4 dangerous mixture,16 and the safety and effective- level measuring teaspoon of table salt. This mixture was calcu- ness of homemade ORS in the United States has not lated to contain 50 mEq/L sodium, 1 mEq/L potassium, and 60 g/L cereal. Group 2 received CBORS, prepared by mixing ingre- been reported. Cereal-based oral rehydration solu- dients from a packet (provided by the Gerber Products Company) tions (CBORS) may be prepared from ingredients with 8 oz of water and containing 60 mEq/L sodium, 15 mEq/L found in most households, and homemade CBORS potassium, 48 mEq/L chloride, 25 mEq/L bicarbonate, and 80 should be safer than homemade sugar–salt solutions g/L cereal. Group 3 received Pedialyte (Abbott Laboratories, Columbus, OH), a commercially available glucose-based ORS (45 because of its lower osmolality if prepared with an mEq/L sodium, 20 mEq/L potassium, 35 mEq/L chloride, 30 17 inappropriately small volume of water. CBORS us- mEq/L citrate, and 25 g/L glucose). ing rice or other cereals at concentrations of 50 to 80 The study nurse assessed the ability of parents assigned to the g/L have been shown to be as effective as glucose- homemade and packet CBORS groups to correctly identify the based solutions in restoring and maintaining hydra- household measures used to prepare the solution. Parents were given all materials necessary to prepare and administer the study tion; in some studies, its use has reduced stool out- solution, including measuring utensils and containers for the put, shortened the course of diarrheal illness, CBORS groups and Pedialyte for the control group. Instructional reduced vomiting, decreased the volume of oral so- leaflets describing how to prepare and administer the study solu- lution needed, and improved weight gain.18,19 tions were given along with leaflets describing recommended feeding practice during diarrhea and prevention of transmission To assess the safety and effectiveness of home- of diarrheal disease. Parents were instructed to give the child made CBORS and CBORS prepared from a packet of her/his usual volume of liquids plus an additional volume, which premeasured dry ingredients, we conducted a ran- the nurse calculated as 10 mL/kg, for each diarrheal stool. They domized clinical trial. The hypotheses tested were 1) were advised to alternate the study solutions with the child’s other when adequately instructed, parents from a variety regular liquids, but to avoid sweetened beverages such as juice or soda pop unless diluted with an equal volume of plain water. It of ethnic and educational backgrounds are able to was suggested that liquids be given from a bottle or cup, but that safely prepare and administer CBORS made from if the child vomited the liquid, to give 1 teaspoonful every few ingredients commonly found in the home or recon- minutes until the vomiting ceased. To ensure uniformity of dietary stituted from a packet of premixed ingredients; 2) advice, parents were also advised to avoid milk and milk formula, but to continue the child’s usual solids. All educational materials CBORS prepared and administered at home are as were available in English, Spanish, and French. Parents also re- effective as commercially available glucose-based ceived diapers; soy formula;A&Dointment (Moore Medical, ORS in maintaining hydration in children with acute New Britain, CT); stickers, marker pens, and plastic bags for diarrheal disease; and 3) CBORS used in the mainte- labeling and collecting soiled diapers; and a canvas tote bag.