RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATE AND ADDRESS / : / DR. HARISH N.V.POST GRADUATE (MD) IN PEDIATRICS,
BANGALORE MEDICAL COLLEGE &
RESEARCH INSTITUTE,
BANGALORE.
S2 / NAME OF THE INSTITUTION / : / BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE.
3 / COURSE OF STUDY AND SUBJECT / : / POSTGRADUATE (MD) IN PEDIATRICS.
4 / DATE OF ADMISSION TO COURSE / : / 2ND MAY 2009
5 / TITLE OF THE TOPIC / : / “PHOTOTHERAPY INDUCED HYPOCALCEMIA IN NEONATES WITH HYPER BILIRUBINEMIA”.
6. BRIEF RESUME OF INTENDED WORK:
6.1 NEED FOR THE STUDY-
Hyperbilirubinemia is a common and in most cases, benign problem in neonates. Jaundice is observed during first week of life in approximately 60% of term neonates and 80% of preterm neonates. Untreated severe unconjugated hyperbilirubinemia is potentially neurotoxic (1).
Phototherapy is one of the routine method for management of hyperbilirubinemia. It plays a significant role in prevention and treatment of hyperbilirubinemia. However, it is not harmless intervention. It can produce adverse effects such as dehydration, temperature instability, skin rashes, loose stools, retinal damage, hypocalcemia ,bronze baby syndrome, redistribution of blood flow and genotoxicity (2-4).
Hypocalcemia is one of the known adverse effect. 90% of preterm and 75% of fullterm neonates develop hypocalcemia after being subjected to phototherapy (4,5). Hypocalcemia can cause serious complication like irritability, jitteriness, convulsion, apnoea . Hence, phototheraphy induced hypocalcemia is a significant problem. It is recommended that in order to prevent hypocalcemia, babies should be given calcium as prophylaxis (6,7).
So this study is undertaken to evaluate the occurrence of phototherapy induced hypocalcemia and to compare it between full term and preterm neonates.
6.2 REVIEW OF LITERATURE:
· Sourabh Dutta, in his study titled “Phototherapy for neonatal jaundice, recent advances and controversies” at PGIMER, Chandigarh, concluded that 90% of preterm neonates and 75% of fullterm neonates with unconjugated hyperbilirubinemia developed hypocalcemia after being subjected to phototherapy (4).
· Harneeth Sethi, in his study titled “Phototherapy induced hypocalcemia” at Lady Harding Medical College, Neonatal division, New Delhi, have shown that 90% of preterm neonates and 75% of fullterm neonates with hyperbilirubinemia treated with phototherapy developed hypocalcemia (5).
· BK Jain, in his study titled “Phototherapy induced hypocalcemia” at department of pediatrics, Dayanand Medical College, Ludhiana, have found that 55% of preterm neonates and 30% of fullterm neonates with hyperbilirubinemia developed hypocalcemia after 48 hours of phototherapy. Of
the preterm neonates, 67.3% had jitteriness and 27.33% had irritability. Among fullterm neonates,50% had jitteriness and 16.7% had irritability. Hence, they concluded that phototherapy induced hypocalcemia is a significant problem and calcium supplementation to these babies may be considered (6).
· F Eghbalian, in his study titled “Phototherapy induced hypocalcaemia in Icteric newborns” at new born ward of Ghaem and Ekbataen Hospitals of Hamadan, have found that serum calcium levels declined considerably after neonates with hyperbilirubinemia treated with phototherapy. The mean duration of phototherapy was three days. Decline in serum calcium level at times reached hypocalcemic threshold. There was direct relationship between duration of phototherapy and development of hypocalcemia. It was recommended that in order to prevent hypocalcemia in phototherapy treated newborns, calcium should be given as prophylaxis (7).
· H Karamifar, in his study titled “Prevalance of Phototherapy induced hypocalcemia” at Division of Endocrinology and Metabolism and Division of Neonatalogy, Department of Pediatrics, Shiraz University of Medical Sciences, Shiraz, Iran, found that prevalance of hypocalcemia was 22.6% in preterm neonates and 8.7% in fullterm neonates after 48 hours of phototherapy for hyperbilirubinemia (8).
6.3 OBJECTIVE OF STUDY
1) To study the occurance of hypocalcemia in neonates with unconjugated hyperbilirubinemia after 48 hours of continuous, double surface phototherapy or at the end of phototherapy, in case duration of phototherapy is less than 48 hours.
2) To compare the occurrence of phototherapy induced hypocalcemia between preterm neonates and fullterm neonates with unconjugated hyperbilirubinemia.
7. MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
130 Fullterm neonates and 45 preterm neonates with uncojugated hyperbilirubinemia admitted to Neonatal Intensive Care Unit at Vani Vilas Children Hospital and Bowring and Lady Curzon Hospital, attached to Banglore Medical College and Research Institute, Bangalore.
7.2 METHOD OF COLLECTION OF DATA.
TYPE OF STUDY:
Hospital based prospective study.
INCLUSION CRITERIA:
1) Fullterm neonates (37 completed weeks to 41 weeks) with unconjugated hyperbilirubinemia requiring phototherapy.
2) Preterm neonates (34 weeks to less than 37 completed weeks) with unconjugated
hyperbilirubinemia requiring phototherapy.
EXCLUSION CRITERIA: New born,
1) with jaundice in first 24 hours of life.
2) to a diabetic mother.
3) with apgar of less than 7 at 5 minutes of birth.
4) whose mother had history of taking anti-convulsants.
5) fed with Cows milk.
6) who had exchange transfusion.
7) with jaundice lasting more than 14 days of life.
8) with sepsis.
Pretest and posttest counseling is given to parents. After written consent from the parents, those neonates fulfilling the above mentioned criteria are subjected to blood test like serum calcium levels, at initiation and after 48 hours of phototherapy or at the end of phototherapy in case duration of phototherapy is less than 48 hours.
STATISTICAL METHODS: 1)Proportions will be compared using chi-square test. 2)Mean between the groups will be compared using T-test or ANNOVA.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?
Investigations: Yes
Blood test for serum calcium levels, at initiation and after 48 hours of phototherapy or at the end of phototherapy, in case duration of phototherapy is less than 48 hours.
Intervention: No
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? YES
8. LIST OF REFERENCES:
1) Anthony J,Piazza and Barbara J Stoll:Jaundice and hyperbilirubinemia in newborn. In: Kliegman, Behrman, Jenson, Stanton(eds) Nelson Text book of pediatrics. 18th edition,Philadephia,Saunders, 2008;756-57.
2) Camilla R,Martin and John P Cloherty:Neonatal hyperbilirubinemia.In: John P. Cloherty, Eri C Eichenward, Ann R Stark(eds) Manual of neonatal care. 6th edition, Philadephia,Lippincott Williams and Wilkins, 2008;201.
3) Meharban Singh: Jaundice.In: Meharban Singh(ed) Care of the newborn. 6th edition, 2004; 253-54.
4) SourabhDutta: Phototherapy for neonatal jaundice, recent advances and controversies. Journal of Neonatalogy 2001;1(1):39-44.
5) Harneet Sethi, Arvind Saili, Dutta AK : Phototherapy induced hypocalcemia. Indian pediatrics 1993;30(12):1403-06.
6) BK Jain, Harmesh Singh, Daljit Singh, NS Toor: Phototherapy induced hypocalcemia. Indian pediatrics 1998;35(6):566-67.
7) F Eghbalian, A Monsef: Phototherapy induced hypocalcemia in icteric newborns. IJMS 2002;27(4):169-71.
8) H Karamifar, N Pishva, GH Amirhakimi: Prevalence of phototherapy induced hypocalcemia. IJMS 2002;27(4):166-68.
9. SIGNATURE OF THE CANDIDATE :
DR.HARISH N.V.
10. REMARKS OF THE GUIDE : Hypocalcemia is a known adverse effect of
Phototherapy. There are only few studies conducted regarding phototherapy induced hypocalcemia. Hence, this is a good study.
11.NAME AND DESIGNATION OF :
11.1 Guide : DR. MALLESH. K
ASSISTANT PROFESSOR
DEPT OF PEDIATRICS,
BANGALORE MEDICAL
COLLEGE AND 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 H.O.D,
DEPARTMENT OF PEDIATRICS,
BANGALORE MEDICAL
COLLEGE AND RESEARCH
INSTITUTE,BANGALORE.
11.6 Signature :
12.1 REMARKS OF THE
CHAIRMAN AND PRINCIPAL :
12.2 Signature :
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