Rajiv Gandhi University Health Sciences

RAJIV GANDHI UNIVERSITY HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE & ADDRESS Dr. OBAID ZAFFER, (IN BLOCK LETTERS) DEPARTMENT OF PEDIATRICS, VIMS & RC, #82, EPIP AREA, WHITEFIELD, BANGALORE – 560066 2. NAME OF THE INSTITUTION VYDEHI INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTRE

3. COURSE OF STUDY & SUBJECT M.D. IN PEDIATRICS

4. DATE OF ADMISSION TO THE COURSE 18th MAY 2010

5. TITLE OF THE TOPIC A CLINICAL STUDY OF LOWER RESPIRATORY TRACT INFECTIONS IN CHILDREN WITH SPECIAL REFERENCE TO MICROBIOLOGICAL AND RADIOLOGICAL CORRELATION IN A HOSPITAL SETTING. 6. BRIEF RESUME OF THE INTENDED WORK

6.1 Need For Study:

Acute lower respiratory tract infections (ALRTI) are the leading cause of mortality and a common cause of morbidity in children below five years of age. In developing countries pneumonia alone kills 3 million children every year. It is responsible for 19% of all deaths in children below five years of age [1]. Of these deaths, 90 to 95% are in the developing countries [2].

Children under the age of five years are most commonly affected by LRTI. Children in the developing world have risk factors that predispose to more severe infections, and often have a limited access to effective medical care. Lack of breast-feeding, upper respiratory infection in mother, upper respiratory infection in siblings, severe malnutrition, inappropriate immunization and history of LRTI in the family were the significant contributors of severe ALRTI in children under five years [3] .

6.2 Review of Literature:

Acute lower respiratory infections (ALRI) are defined in the International Statistical Classification of diseases and related health problems, tenth revision, as those infections that affect the airways below the epiglottis [4]. These include acute manifestations of laryngitis, tracheitis, bronchitis, bronchiolitis, lung infections, any combination of these or any of these along with upper respiratory infections including influenza. Etiologic classification of lower respiratory disease: i. Acute laryngotracheobronchitis or croup ii. Tracheobronchitis iii. Bronchiolitis iv. Pneumonia

In North America and Europe (9 studies), the etiology of pneumonia was established in 62% of studied children (range 43%- 88%) by use of noninvasive specific methods for microbiologic diagnosis [5].

Several studies have demonstrated that chest radiography is 42-73% accurate in predicting the etiology of a case of pneumonia. The total WBC and differential count may aid in determining if an infection is bacterial or viral, and, together with clinical symptoms, chest radiography and ESR can be useful in monitoring the course of pneumonia. In a study of 168 patients with known pneumonia, Wubbel et al found only sterile blood cultures. In general, blood culture results are positive in 10-15% of patients with streptococcal pneumonia. The numbers are even less in patients with Staphylococcus infection. A blood culture is still recommended in complicated cases of pneumonia [6].

In comparison to the few other studies done on anemia and LRTI, Ramakrishnan et al in 2006 found, in a study of 200 infants and children between 9 months to 16 years, that 74% of cases and 33 % of controls were anemic (with 80% and 82 % IDA, respectively). Boys were more anemic than girls, and the anemic subjects were 5.7 times more susceptible to LRTI . Malla et al, in 2010 in a study done on a total of 280 infants and children aged 1 Months to 5 years, recorded 68.6% of anemic cases and 21.4 % of anemic controls with mean Hb level of 9.8 g/dl and 12 g/dl, 82% and 60 % of IDA, respectively. Eighty three percent of the anemic group had a picture of pneumonia on chest radiograph. Anemia due to mainly IDA was a risk factor for LRTI with an Odds Ratio of 3.2 [2].

As is evident from these studies, identifying the correlation between the clinical, radiological and microbiological aspects of LRTIs will help in better understanding of the disease pathology as well as the course of the disease, and thus aid in managing the disease in a better way.

Vydehi Institute Of Medical Sciences and Research Centre, Bangalore is a tertiary care centre with facilities available for complete evaluation of LRTI patients. In the detailed evaluation of LRTI’s, microbiological and radiological investigations are done frequently. We need to know the correlation between clinical, microbiological and radiological results in LRTIs. Hence the present study is taken up to study correlation of clinical presentation with microbiological results and radiological findings in LRTI’s.

6.3 OBJECTIVES OF THE STUDY:

The present study is undertaken with the following aims and objectives: 1. To study the clinical spectrum of Lower Respiratory Tract Infections in children in VIMS & RC.

2. To correlate clinical profile with laboratory investigations like total count, differential count, blood and throat swab culture with antibiotic sensitivity along with isolation of organism wherever possible.

3. To correlate clinical profile with radiological findings.

7. MATERIALS & METHODS:

7.1 Source of Data: All children less than 18 years of age attending to Pediatric Department of Vydehi Institue of Medical Sciences & Research centre satisfying the Inclusion Criteria will be evaluated by collecting baseline data of the child, clinical evaluation & the necessary investigations. a) Duration of study:  The study will be a duration based study conducted over 1 year with a minimum of 50 cases.  Period Of Study: 1st December 2010 to 30th November 2011. b) INCLUSION CRITERIA:  Children below 18 years of age.  All children with Lower Respiratory Tract Infections i.e Acute laryngotracheobronchitis or croup / Tracheobronchitis / Bronchiolitis / Pneumonia {with symptoms like fever, cough, change in voice, shortness of breath, wheezing, or difficulty in breathing with tachypnoea and chest indrawings seen in the severe form} [7]. c) EXCLUSION CRITERIA:  Where age is more than 18 years  LRTI cannot be proved on clinical, microbiological and radiological evaluation  All Lower Respiratory Tract Diseases other than Lower Respiratory Tract Infections like asthma, GERD etc.

7.2 Method of Collection of Data

It will be a prospective study conducted over a period of 1 year from 1st Dec 2010 to 31st Nov 2011.

Sampling:  All children attending the Department of Pediatrics at VIMS & RC satisfying the inclusion criteria in the study period will be included in the study.

Statistical Analysis:

 Data will be analyzed using following statistical parameters – Percentage and Proportions.

7.3 Does the study require any investigations and interventions to be conducted on the patients?

 Yes- Haemogram , blood culture, throat swab culture, Chest X – ray and other relevant investigations like bronchoscopy etc. depending upon clinical diagnosis.

7.4 Has ethical clearance been obtained from your institution? YES 8. References

1. Etiology of Acute Lower Respiratory Tract Infection Kabra S.K., Lodha R., Broor S., Chaudhar R., Ghosh M., Maitreyi R.S. India,Indian Journal of Pediatrics, Volume 70---January, 2003 2. Mourad S, Rajab M, Alameddine A, Fares M, Ziade F, Abou Merhi B. Hemoglobin level as a risk factor for lower respiratory tract infections in Lebanese children. North Am J Med Sci 2010; 2: 461-466. Doi: 10.4297/najms.2010.2461 Availability: www.najms.org North American Journal of Medical Sciences 2010 October, Volume 2. No. 10. 3. Broor S., Pandey R.M., Ghosh M., Maitreyi R.S., Lodha R., Singhal T., Kabra S.K. Risk Factors for Severe Acute Lower Respiratory Tract Infection in Under-Five Children. Indian Pediatrics 2001; 38: 1361-1369 . 4. International Journal of Epidemiology 2004;33:1362–1372, Advance Access publication 27 May 2004 5. Nascimento-Carvalho Cristiana M.C.. Etiology of childhood community acquired pneumonia and its implications for vaccination. Brazilian journal of infectious diseases[serial on the Internet]. 2001 Apr[cited 2010 Oct 15];5(2): 87-97. Available from: http://www.scielo.br/scielo.php? script=sci_arttext&pid=S1413-86702001000200007&lng=en. doi: 10.1590/S1413- 86702001000200007. 6. Bennett N.J., Domachowske J., Virella-Lowell I. Pneumonia: Differential Diagnoses & Workup avilable at {medscape > eMedicine Specialties > Pediatrics: General Medicine > Infectious Disease-967822-diagnosis} 7. Bell M., Birmingham M., Cardo D.M., Chamberland M., Chartier Y., Ching P., et al. Infection prevention and control of epidemic and pandemic prone acute respiratory diseases in health care. WHO Interim Guidelines. June 2007 { WHO/CDS/EPR/2007.6 } 9. Signature of the candidate

10. Remarks of the guide : Lower respiratory tract infections are important causes of morbidity and preventable mortality. This study will throw light on the evaluation of LRTI in children.

11. Name & Designation of (In block letters)

11.1 Guide Dr. SUBRAMANYA N.K. MBBS,MD ASSOCIATE PROFESSOR DEPARTMENT OF PEDIATRICS VIMS AND RC BANGALORE 11.2 Signature

11.3 Co - Guide (if any) 11.4. Signature

11.5 Head Of Department Dr. M.L. SIDDARAJU MBBS,MD PROFFESOR AND HOD DEPARTMENT OF PEDIATRICS VIMS AND RC BANGALORE 11.6 Signature

12. 12.1 Remarks of the Chairman & Principal

12.2 Signature INFORMED CONSENT FORM

I ………………………………………………………(Name of Parent/ Guardian) exercising free power of choice, hereby give my written consent to include my child as a subject in the study of LOWER RESPIRATORY TRACT INFECTIONS IN CHILDREN WITH SPECIAL REFERENCE TO MICROBIOLOGICAL AND RADIOLOGICAL CORRELATION IN A HOSPITAL SETTING conducted by Dr. Obaid Zaffer, Post-graduate in Pediatrics, VIMS & RC , Bangalore, under the guidance of Dr. SUBRAMANYA N.K. , Associate Professor in Pediatrics, VIMS & RC, Bangalore. I also give consent for blood tests, throat swab culture & chest X-ray and other relevant investigations to be done for my child as required for the study.

I have been informed to my satisfaction by the investigator in the language that I understand about the purpose of the study. I was given the opportunity to discuss and to seek clarification regarding the condition of my child. I have also understood that the investigator will maintain confidentiality, regarding my identity. Further I here by declare that I have not been forced by the investigator to participate in the study.

… … … … … … … … … … … … ………………………………

Signature of the Parent/Guardian Dr. Obaid Zaffer

Name of the Parent/Guardian:

Relation with the Child:

Date and Place: PROFORMA

Informant : Name : Age : IP No : Sex : DOA : Religion : DOD : Address : Duration of stay : Diagnosis : Results : Improved / expired

Presenting complaints with duration: a) Fever –  Degree - Mild/ moderate/ high  Type - Continuous/ intermittent/ remittent. b) Cough –  Type - Dry/ wet,  postural variation – (Y/N) ,  Variation – Day/ Night / NA  Spasmodic, associated with vomiting c) Running nose / headache / malaise / sore throat. d) In drawing- Intercostal / subcostal / suprasternal / flaring of alaenasi/ all e) Stridor – Inspiratory / Expiratory/ Both f) Wheeze- inspiratory / expiratory /both g) Pain in the chest - continuous/ increase on deep inspiration. h) History of cyanosis - central / peripheral i) Hoarseness – Y/N j) History of past attacks of RTI – Y/N, No. of attacks - _____ k) Vomiting / diarrhoea l) Feeding – Accepting / Reduced/ Cant be fed m) Skin rash / pyoderma – Y/N n) H/O Foreign Body aspiration – Y/N o) Any other symptoms – Past history :

Infectious diseases – measles / whooping cough/ Tuberculosis / URTI / pyoderma / worm infestation any other – Y/N

Family history : Order of birth and consanguinity - H/o Tuberculosis, asthma or any other illness –Y/N Number of siblings - Any family member with similar history – Y/N H/O atopy in any family member – Y/N Socioeconomic and environmental history:

Total income of family – Per capita income – Pets – Y/N Over crowding – Y/N Nutritional History Breast fed-duration - Adequate or not Weaning - Top milk quantity Other articles of diet Total number of calories & proteins

 Consumed-

 Expected-  Deficit- Antenatal History

Whether regular ANCs were done- Y/N

Birth history

Full term / Preterm / Post term Nature of delivery- Normal Vaginal Delivery/ LSCS Breastfed within- H/o Birth Asphyxia- Y/N Any other complication 1. 2. 3. 4. Post Natal history

Exclusively breastfed till - Weaning started with - Any h/o jaundice/ fever/ vomiting / diarrhoea or any other illness during postnatal period ? H/o NICU admission or any hospitalization for any reason ? Immunisation status

 BCG & OPV- 0 - Y/N

 OPV 1 & DPT 1- Y/N

 OPV 2 & DPT 2- Y/N  OPV 3 & DPT 3- Y/N

 Measles- Y/N

 OPV & DPT Booster – Y/N

 MMR – Y/N

 Hib- Y/N

 Pneumococcal- Y/N

 Influenza- Y/N

Developmental History Gross Motor – Normal/ Regressed / Delayed Fine Motor – Normal/ Regressed / Delayed Psychosocial – Normal/ Regressed / Delayed Language – Normal/ Regressed / Delayed

General physical examinations:

Head to toe:  Eyes – Normal / Discharge / Congested

 Ears – Normal / Discharge / Congested

 Nose – Normal/ Rhinnorhea / Congested

 Throat – Normal / Post. Pharyngeal wall congestion/ Abscess / Ulcer

 Neck lymphadenopathy – Y/N

 Skin – Normal / Pyoderma Vital signs

Temperature - Pulse -

Respiratory Rate - BP -

SpO2 -

Pallor - Icterus -

Jaundice - Oedema -

Clubbing - Lymphadenopathy –

Anthropometry

Observed Expected Percentile Weight Height/Length Head circumference Chest circumference Mid-arm circumference Grade of malnutrition (IAP)

I – Y/N

II – Y/N

III – Y/N

IV – Y/N Systemic examination –

Respiratory system : Inspection/palpation • Shape of the chest • Movements of chest • Position of trachea – Right/ Left/ Central • Position of A.I (Apical impulse) • Type of Respiration - Abdominothoraxic/ Thoracoabdominal • Indrawing – suprasternal / inter costal / subcostal • Vocal fremitus • Inter costal tenderness Percussion

 Resonant / Hyper resonant / Impaired / Stony dullness

 Liver/Cardiac Dullness- Auscultation

 Air entry – normal/diminished/absent

 Breath Sounds – vesicular/bronchial (tubular – cavernous/amphoric)

 Vocal resonance – normal/increased diminished

 Adventitious sounds – crepitations/ronchi/wheeze

Cardiovascular system

 Etiology of CHD- Y/N

 Etiology of Left to Right Shunt- Y/N

 Etiology of CCHD- Y/N

 Etiology of Pulmonary Hypertension- Y/N Per abdomen Hepatomegaly / Spleenomegaly / Hepatospleenomegaly / Free fluid ?

Central nervous system Etiology of long standing neurological diseases ?

Investigations : Blood Haemoglobin value- Normal/ Increased/ Decreased

TLC – Leucocytosis / Leucopenia / Normal

 Polymorphs - Normal/ Increased/ Decreased

 Lymphocytes - Normal/ Increased/ Decreased

 Eosinophils - Normal/ Increased/ Decreased

 Monocytes - Normal/ Increased/ Decreased

 ESR - Normal/ Increased/ Decreased

 Peripheral smear – Normocytic Normochromic/ Microcytic Hypochromic/ Dimorphic

 Platelets - Normal/ Increased/ Decreased

Urine examination – albumin / sugar / microscopic – Normal / Abnormal

Stool – microscopy & reducing substance test – Normal / Abnormal

X-ray chest :  Rotation – Y/N  AP / Lateral-

Alveolar Shadow Interstitial Shadow Right – Upper Zone (UZ) Middle Zone (MZ) Lower Zone (LZ) Left - Upper Zone (UZ) Middle Zone (MZ) Lower Zone (LZ)

RUZ RMZ RLZ LUZ LMZ LLZ Consolidation Atelectasis Interstitial Pneumonia Lymphadenopath y Pleural Effusion Air Trapping Increased BVM

Radiological Diagnosis -

Microbiological investigations :

Throat swab  Organism Isolated- ______

Blood culture

 Organism Isolated- ______

 Antibiotic sensitivity- ______

Microbiological Diagnosis -

Treatment given

 Symptomatic/ Conservative- Y/N

 Antibiotics- Y/N Final Diagnosis -