RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the candidate
And
Address
(in block letters) / DR.SAJJAD SANEEQ CH
M V J MEDICAL COLLEGE & RESEARCH HOSPITAL, BOYS HOSTEL, ROOM NO.G-2, DANDUPALYA, HOSAKOTE, BANGALORE-562114
2. / Name of the institution / M.V.J. Medical College And Research Hospital
3. / Course of study and subject / M.D. Pediatrics
4. / Date of admission to course / 3 MAY 2010
5. / Title of the topic
Correlation of Cord blood bilirubin and neonatal hyperbilirubinemia in newborns with a setting of ABO incompatibility
6. / Brief resume of the intended work
6.1 Need of the study
1.  Early discharge of healthy term newborns after delivery has become a common practice. One of the most common causes for readmission during the early neonatal period is Neonatal hyperbilirubinemia (NH). For those neonates who do not come for follow up & are left untreated at home, NH can lead to Bilirubin Encephalopathy.
2.  Rh-incompatibility, a major risk factor of NH, is nowadays prevented with effective strategies. This has led to reduction of incidence of Rh- incompatibility induced bilirubin Encephalopathy. As a result, among different risk factors, ABO incompatibility has emerged as a commonest cause of NH.
3.  A setting of ABO incompatibility occurs in ‘A’ and ‘B’ blood group babies born to mothers of O blood group.
4.  Prediction of NH using Cord blood bilirubin (CBB) offers a non-invasive option to pick up Healthy Term Newborns at risk of ABO incompatibility.
5.  We want to find out a cut-off level of CBB for predicting the development of NH in healthy term newborns of rural Bangalore who are at risk of ABO incompatibility.
6.2  Review of literature
ABO incompatibility occurs in ‘A’ and ‘B’ blood group babies of ‘O’ blood group mothers. Incidence of NH in Nepal was 28.8% among newborns who had a setting of ABO incompatibility. The chance of developing NH in these newborns within 72 hours was 2.6 times higher.1 ABO-incompatible babies have double risk to develop jaundice requiring treatment and 5-10 times increased risk of exchange transfusion.2 Nearly 20% of all pregnancies are associated with a setting of ABO incompatibility but <10% of these manifests ABO-Haemolytic diseases of the newborn.3 A cord bilirubin level >2.5mg/dl predicts development of pathological jaundice (defined as bilirubin >13mg/dl) with sensitivity of 71% and specificity of 96%.4 CBB offers an attractive option to pick up the healthy term Newborns who are at risk of NH.4,5
6.3 Objectives of the study
1.  The present study will be conducted to correlate the CBB level with subsequent NH in ‘A’ and ‘B’ Blood group babies born to ‘O’ Blood group mothers.
2.  To find out a cut-off level of CBB for Predicting the Development of NH in Healthy Term Newborns who are at risk of ABO incompatibility.
7. / Material and methods
7.1 Source of data
This study will be performed at the Department of Paediatrics of M.V.J. Medical College & Research Hospital
7.2 Method of collection of data (including sampling procedure, if any)
Eligible healthy full-term newborns (200 in numbers) born at this hospital will be prospectively enrolled in the study. The demographic profile and relevant information of individual patient will be collected using structured Proforma by interviewing the mother and an informed consent will be obtained. Gestational age will be assessed by new Ballard score. CBB will be estimated. Serum bilirubin estimation will be done at 72 hours of age. Babies will be followed up as and when clinically indicated.
Inclusion criteria
1.  Healthy full-term newborns born to O blood group mothers.
Exclusion criteria
1.  Rhesus blood factor incompatibility.
2.  Significant illness requiring NICU admission.
3.  Major congenital malformations.
4.  Chronic maternal illness (like DM).
5.  Those who didn’t give their consent for follow up
7.3 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so please describe briefly.
Cord blood will be collected to determine the blood group and to estimate the bilirubin level which is non-invasive. Serum Bilirubin estimation will be done as per Paediatric Department management protocol for NH.

Statistical Analysis

The obtained data will be entered into MS Excel. Association of hyperbilirubinemia will be analyzed with the independent sample t test and the descriptive analysis. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) for MS Windows.
7.4 Has ethical clearance been obtained from your institution in case of 7.3
Obtained.
8. / List of references (About 4 – 6 )
1.  Kalakheti B.K, Singh R, Bhatta N.K. Risk of Neonatal Hyperbilirubinemia in babies born to O positive mothers: A Prospective cohort study. Kath Univ Med J (2009) ;25:11-15.
2.  Heier HE, FugelsethD, LindemannR, QvigstadE. Maternal blood group O as a risk factor of neonatal hyperbilirubinemia requiring treatment. Tidsskr Nor Laegeforen 1996;116:34-36.
3.  Blanchette V, Doyle J, Schmidt B, Zipursky A. Haematology in Neonatology. In: Avery GB, Fletcher MA, MacDonald MG. Pathophysiology and management of the newborn. 4th ed. Philadelphia: Lippincott Company; 1994. P. 952-99.
4.  Agarwal R, Kaushal M, Aggarwal R, Paul VK, Deorari AK. Early Neonatal Hyperbilirubinemia Using First Day Serum Bilirubin Level. Indian Pediatr 2002; 39: 724-730.
5.  Rossenfeld J.Umbilical cord bilirubin levels as predictor of subsequent hyperbilirubinemia. J Fam Pract 1986; 23:556-58.
9. / Signature of candidate
10. / Remarks of the guide
The study is highly recommended as there is a real need for such a research to predict neonatal hyperbilirubinemia in rural setup.
11. / Name and designation of
(in block letters)
11.1 Guide
Dr. SANJEEV. SHRINIVAS. MANAGOLI
PROFESSOR
DEPT. OF PEDIATRICS
M.V.J. MEDICAL COLLEGE AND RESEARCH HOSPITAL
11.2 Signature of guide
11.3 Co-guide (if any)
11.4 Signature
11.5 Head of the department
Dr. B. RAVI CHANDER
PROFESSOR AND HOD
DEPT. OF PEDIATRICS
M.V.J. MEDICAL COLLEGE AND RESEARCH HOSPITAL
11.6 Signature
12 / 12.1  Remarks of the Chairman and Principal
12.2 Signature