RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE – II

Proforma for Registration of Subjects for Dissertation

|1. |NAME OF THE CANDIDATE AND ADDRESS |: |DR. KIRANKUMAR |

| | | |POST GRADUTE IN PEDITRICS, ROOM NO – 66, BMC |

| | | |BOYS PG |

| | | |HOSTEL, CHAMARAJPET |

| | | |BANGALORE – 560 018. |

|2. |NAME OF THE INSTITUTION |: |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE. |

|3. |COURSE OF STUDY AND SUBJECT |: |M.D. IN PEDIATRICS. |

|4. |DATE OF ADMISSION TO THE COURSE |: |03-05-2010 |

|5. |TITLE OF THE TOPIC |: |STUDY TO IDENTIFY THE NEWBORNS AT RISK FOR DEVELOPING |

| | | |HYPERBILIRUBINEMIA BY MEASURING CORD BLOOD BILIRUBIN AT BIRTH. |

6. BRIEF RESUME OF THE INTENDED WORK: 

6.1 NEED FOR THE STUDY:

             Jaundice is a clinical condition that is present in pediatric practice and constitutes one of the major issues within the neonatal period. It occurs in both physiological and pathological processes in newborns.1 Neonatal hyperbilirubinemia is defined as significant when serum bilirubin levels more than or equal to 17mg/dl. Neonatal jaundice may not appear until serum bilirubin exceeds 5-7mg/dl.2

              Early discharge of newborn after delivery is a common practice because of medico-social reasons and economic constraints. Thus the recognition, follow up and treatment of jaundice has become more difficult as a result of early discharge from hospital. An association between decreased length of stay and the risk of re-admission has been shown and the most common cause for re-admission during neonatal period is   Hyperbilirubinemia.2 Concerns regarding early discharge and hyperbilirubinemia in newborn has been subject of many controversies. Early hospital discharge has had the implication of re-examining the approach towards neonatal jaundice, taking into consideration the bilirubin level present in the first 24 hours to 48 hours of life as a means of predicting   hyperbilirubinemia.1

       A reliable clinically evaluated method for estimation of the risk of bilirubin dependent brain damage is still lacking. Physical examination is not a reliable measure of serum bilirubin. Under these circumstances it would be desirable to be able to predict the risk of hyperbilirubinemia, in order to implement early treatment and minimize the risk of bilirubin dependent brain damage.2

        Present study is undertaken to know whether bilirubin levels found in the cord blood at birth could predict hyperbilirubinemia severity among full term newborns without complications.

       

6.2   REVIEW OF LITERATURE:

           In a study on full term neonates, Bernaldo AJ et al. concluded that values of cord blood unconjugated bilirubin was significantly higher in newborns who required photo therapy. The cord blood bilirubin levels greater than 2 mg/dl had a 53% probability of the need for further treatment with phototherapy.1

        Amar Taksande et al. in their study on healthy term neonates, concluded that the cord blood bilirubin level of more than 2 mg/dl had the highest sensitivity (89.5%), and this critical bilirubin level also had a very high (98.7%) negative predictive value and a low (38.6%) positive predictive value.  This high negative predictive value suggested that measurement of cord blood bilirubin can help in identifying newborns who are unlikely to require further evaluation and intervention.2

        Zakia Nahar et al. had undertaken a study on healthy newborn infants and concluded that measurement of total serum bilirubin level in cord blood has predictive value in neonates who would develop significant hyperbilirubinemia warranting therapeutic intervention. The cut off value of 2.5mg/dl umbilical cord blood bilirubin can predict significant hyperbilirubinemia with high negative and positive predictive values and high levels of sensitivity and specificity.3

       Sun G et al. had undertaken a study on healthy term newborns found that the frequency of patients with hyperbilirubinemia requiring phototherapy increased with increasing umbilical cord bilirubin level. The cord serum bilirubin levels more than or equal to 2 mg/dl had a significant positive predictive value to detect infants at low or high risk for hyperbilirubinemia and thus minimize an unnecessary prolongation of hospitalization.4

      Suchonska B et al. in their study on healthy full term neonates found that the concentration of bilirubin in the cord blood can be useful indicator of risk of icterus in newborns and special care is needed for newborns whose concentration of bilirubin in cord blood is more than 1 mg%.5

      Knupfer M et al. in their study on healthy term and near term neonates found that umbilical cord serum bilirubin cut-off level of 30 μmol/l(1.76 mg/dl), had a sensitivity of 90% and a negative predictive value of 99.1%, indicating that all neonates with umbilical cord serum  bilirubin levels below 30 μmol/l (1.76mg/dl) were at a very low risk of developing dangerous hyperblirubinemia. The data suggested that umbilical cord serum bilirubin is useful in predicting the postnatal bilirubin values in term and near-term newborns and helps to detect neonates at low risk for postnatal hyperbilirubinemia and thereby unnecessary prolongation of hospitalization can be prevented 6

       

3.     AIMS AND OBJECTIVES OF THE STUDY:

1. To evaluate the correlation between concentration of bilirubin in the cord blood and occurrence of hyperbilirubinemia in term newborns.

2. To estimate critical cord blood bilirubin level as a predictor of significant hyperbilirubinemia. 

 7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA: - Study subjects include 500 healthy full term newborns born in Vani Vilas Hospital and Bowring and Lady Curzon Hospital attached to Bangalore Medical College and Research Institute during the study period from October 2010 to September 2012.

7.2 METHOD OF COLLECTION OF DATA: -

Informed consent will be obtained from all the parents of the newborns to be enrolled for the study. In all the newborns, relevant information will be collected in a predesigned proforma.

The cord blood bilirubin estimation will be done at birth and serum bilirubin level will be done after 72 hours of birth. The cord and serum bilirubin estimation will be done using - Modified Jendrassik-Grof method, a photometric method for estimation of direct and total bilirubin. All the neonates will be observed for the development of jaundice for at least 5 days.

7.3    INCLUSION CRITERIA:-

Gestational age more than 37 weeks. 

7.4 EXCLUSION CRITERIA:-

Gestational age less than 37 weeks

Birth weight less than 2500 grams.

Newborns with significant illness requiring admission.

Newborns with major congenital malformations. 

Newborns with blood group incompatibility.  

7.5 Does the study require any investigation or interventions to be conducted on patients or other human beings or animals?  If so please describe briefly? YES

      In the present study investigations will be conducted in term neonates which includes-

      1. Cord blood bilirubin estimation at birth.

      2. Serum bilirubin estimation after 72 hours of birth.

3. Blood group of mother and newborn baby. If blood group incompatibility is found then hemoglobin, peripheral smear, reticulocyte count and direct coombs test will be done.

7.6 Has the ethical committee clearance has obtained for this study from your Institution? TO BE OBTAINED.

7.7 STATISTICAL ANALYSIS

This study is a hospital based prospective study. Statistical methods used are the student t test, descriptive analysis and Chi square tests. The critical cord bilirubin level having the highest sensitivity will be determined with receiver operating characteristics (ROC) curve analysis. 

8. LIST OF REFERENCES:

1. Bernaldo NJA, Segre MAC. Bilirubin dosage in cord blood: could it prevent neonatal hyperbilirubinemia?  Sao Paulo Med J 2004; 122(3): 99-103.

2. Taksande A, Vilhekar K, Jain M, Zade P, Atkari S, Verkey S. Prediction of the development of neonatal hyperbilirubinemia by increased umbilical cord bilirubin. Current Pediatric Research 2005; 9 (1&2): 5-9.

3. Nahar Z, Shahidullah MD, Mannan A, Dey KS, Mitra U, Selimuzzaman SM. The value of umbilical cord blood bilirubin measurement in predicting the development of significant hyperbilirubinemia in healthy newborn. Bangladesh Journal Child Health 2009; 33(2): 50-54

4. Sun G, Wang YL, Liang JF, Du LZ. Predictive value of umbilical cord bilirubin in predicting subsequent neonatal jaundice. Zhongua Er Ke Za Zhi 2007; 45(11): 848-852.

5. Suchonska B, Wielgos M, Bobrowska K, Marianowski L. Concentration of bilirubin in the umbilical blood as an indicator of hyperbilirubinemia in newborns. Ginekolgia Polska; 2004; 75(10): 749-753.

6. Knupfer M, Pulzer F, Gebauer C. Predictive value of umbilical cord blood bilirubin for postnatal hyperbilirubinemia. Acta Paediatr; 2005; 94: 581-587.

7. Ives Kevin N. Neonatal jaundice. In: Roberton's Textbook of neonatology; 4th Ed. Edinburgh: Elsevier publication; 2005: 661-678.

8. Singh M. Jaundice. In: Meharban Singh. Care of the Newborn; 7th Ed. New Delhi: Sagar publication; 2010: 254-274. 

|9. |SIGNATURE OF THE CANDIDATE |: | |

| | | | |

| | | |DR. KIRANKUMAR |

|10. |REMARKS OF THE GUIDE |: |Cord blood bilirubin level will help in early and rapid screening of |

| | | |neonates in need of treatment. Hence the study is taken up to |

| | | |determine the critical cord bilirubin level. |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

|11. |NAME & DESIGNATION OF GUIDE | | |

|11.1 |GUIDE |: |DR. GANGADHAR B. BELAVADI |

| | | |PROFESSOR AND HOD, |

| | | |DEPARTMENT OF PEDIATRICS, |

| | | |BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE BANGALORE. |

|11.2 |SIGNATURE |: | |

|11.3 |CO-GUIDE |: | |

|11.4 |SIGNATURE |: | |

| | | | |

|11.5 |HEAD OF THE DEPARTMENT |: |DR. GANGADHAR B. BELAVADI |

| | | |PROF. AND HOD, |

| | | |DEPARTMENT OF PEDIATRICS, |

| | | |VANIVILAS HOSPITAL, |

| | | |BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE. |

|11.6 |SIGNATURE |: | |

| | | | |

|12.1 |REMARKS OF THE CHAIRMAN & PRINCIPAL |: | |

| | | | |

| | | | |

| | | | |

|12.2 |SIGNATURE | | |

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download