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A STUDY ON THE EFFECTIVENESS OF UMBLICAL CORD BLOOD ALBUMIN AS A PREDICTOR OF NEONATAL HYPERBILIRUBINEMIA IN HEALTHY NEONATES.PRINCIPLE INVESTIGATOR : Dr. G. ShobanaGUIDE : Dr. R. LakshmiCO GUIDE : Dr. Nibedita MitraHEAD OF THE DEPARTMENT : Dr. Nibedita Mitra, Department of Paediatrics, Southern Railway Headquarters Hospital, PeramburINTRODUCTIONNeonatal Jaundice or icterus neonatorum has been observed in newborn babies for many centuries.(1) About 84% of the newborns are affected by neonatal hyperbilirubinemia and it is considered as the commonest cause for readmission to the hospital during this period.(2) Severe hyperbilirubinemia is when the total serum bilirubin (TSB) level is more than 20 mg per dL and it occurs in less than 2% of term infants and can lead to kernicterus. Hence it is important to evaluate all newborns for clinical signs of hyperbilirubinemia.Physiological hyperbilirubinemia is a result of immature liver cell which have low uridine diphospho glucuronosyl transferase activity when compared to mature hepatocyte, low concentration of albumin which is a bilirubin binding ligand, and increased number of erythrocytes which have a shorter life span. Physiological jaundice is a normal response on the part of the baby due limitations in the ability to excrete bilirubin. Neonates develop an unconjugated hyperbilirubinemia due to increased level of unconjugated Bilirubin above 1.0 mg/dl. Early treatment with phototherapy is effective, simple and cheap. This is the appropriate treatment for exaggerated neonatal jaundice.(5)Liver is the site of synthesis of albumin. It binds to unconjugated bilirubin and helps in the transport. This in turn reduces the bilirubin toxicity on the tissues and thereby competing with tissues for bilirubin binding. Extremely avid binding to albumin may be detrimental, however, because it limits the rate of hepatic removal of unconjugated bilirubin from the plasma.(6,7) Low production of albumin will lower its transport and binding capacity and hence determination of at risk neonates early on will help to avoid the complications associated with neonatal jaundice.(8) Free bilirubin circulates in the body when the level of albumin is low and this is toxic to the body. In term babies physiological jaundice is seen to appear between 36 to 72 hours of age, maximum intensity of jaundice is seen on 4th day of life. Serum bilirubin doesn’t exceed 15mg/dl and jaundice disappears by 10th day of life. And physiological jaundice never appears before 24 hours of life (6)The present study is conducted to find out the critical value of cord blood albumin in predicting the subsequent development of significant neonatal jaundice requiring interventions like phototherapy or exchange transfusion.By measuring cord blood albumin level, free bilirubin can be indirectly determined and neonatal hyperbilirubinemia can be identified. This could help in identifying the babies requiring intervention and those who do not and hence early discharge planning is possible.(9)AIMS AND OBJECTIVES1)To study the association between umblical cord blood albumin level and subsequentdevelopment of hyperbilirubinemia in healthy term newborns.2)To analyse the prevelance of hyperbilirubinemia in healthy term neonates. 3)To study the range of umblical cord blood serum albumin in healthy term neonates.METHODOLOGYPopulation : All healthy term neonates born in Southern Railway Headquarters Hospital in the study period.Study period : July 2016 to December 2017Study design : A prospective studyStudy place : Southern Railway Headquarters Hospital, Perambur, ChennaiInclusion criteriaHealthy term babies of both genders, birth weight >2.5 kg and Apgar more than 7 at 1 min and 5 minutes of life.Exclusion criteriaPreterm, Rh incompatibility, Neonatal sepsis, Birth asphyxia, respiratory distress, meconium stained liquor, instrumental delivery and neonatal jaundice within 24 hours of life.Sample specificationsSample size was calculated assuming the expected prevalence of neonatal hyperbilirubinemia as 43.6%.The expected sensitivity and specificity of cord bilirubin were assumed to be 71.8% and 65.1% as per the previous study by Aiyappa GKC et al. The other parameters considered for sample size calculation include 10% absolute precision and 95% confidence level. The following formula was used for sample size calculationn=Z2P1-Pd2 Where n = Sample sizeZ = Z statistic for a level of confidence= 1.96P = Expected sensitivity(If the expected prevalence is 71.8%%, then P = 0.718), and d = Precision (If the precision is 5%, then d=0.10)n=1.962 0.7181-0.282(0.1)2 =77.78N= n / prevalenceN= 77.78 / 0.436 N=178.40So a total of 179 subjects are needed to be included in the final anlaysis. To account for about 5% loss to follow up/ non participation another 9 subjects will be sampled. Hence a total of 188 subjects will be sampled, so that final analysis can include not less than 179 subjects.Method :This was a hospital based, prospective study and was conducted in the department of paediatrics, Southern railway headquarters hospital, Perambur. The study group consisted of 150 simultaneously born full term healthy neonates delivered at southern railway headquarters hospital between July 2016 to December 2017. Ethical clearance was obtained from the institutional research board of Southern railway headquarters hospital. Informed consent was obtained from the parents or guardian.Albumin in umblical cord blood was measured using bromo cresol green reagent in automated analyser. Baby was followed up for presence of icterus using kramer’s rule. Hyperbilirubinemia was diagnosed using bilirubin levels reference to bhutani chart. The need for phototherapy or exchange transfusion to treat hyperbilirubinemia is noted and the variables compared.Statistical analysis : Data was analyzed by test parameters (proportions, sensitivity, specificity, positive and negative predictive value) and Statistical significance test applied are chi square test or Analysis of variance (ANOVA) testREVIEW OF LITERATUREA study done by Sahu et al showed that 70% neonate who developed significant neonatal hyperbilirubinemia had cord serum albumin level <2.8 g/dl, 30% neonate has cord serum albumin level 2.9-2.2 g/dl and none of the neonates with cord serum albumin level >3.4 g/dl developed neonatal hyperbilirubinemia.(6)Study by George et al showed that 6 (85.71%) neonates with albumin level less than 2.8 g/dl developed Hyperbilirubinemia requiring phototherapy within 24-48 hours of life. Among neonates who had albumin levels 2.8-3.3 g/dl, only 12 (35.29%) developed Hyperbilirubinemia requiring phototherapy. Only 2 (22.2%) neonates who had albumin levels of >3.3 developed Hyperbilirubinemia requiring phototherapy.(9)In a study conducted by Meena et al out of 100 neonates 95.5%, 79.4%, 36.4% newborns developed jaundice in group A, B, and C respectively. In group A, 81.8% required phototherapy and 9.1% required exchange transfusion. In group B 26.5% required phototherapy and no one required exchange transfusion, while in group C only 2.3% required phototherapy and none of them requiring exchange transfusion.(10)Trivedi et al,conducted a study on 605 infants, 205 babies developed hyperbilirubinemia of which 120 (58.5%) babies had cord serum albumin level < 2.8gm/dl, 59 (28.8%) babies had cord serum albumin level in the range of 2.8 – 3.5 gm/dl, whereas 26 (12.7%) babies developed hyperbilirubinemia even though cord serum albumin level was more than 3.5 gm/dl. (p <0.05) (7) Pahuja M et al in their study had noted that predictive value of cord albumin for development of neonatal hyperbilirubinemia was 75% which implies a fair predictive value of the criteria with 61.3% sensitive and 76.8% specific.(3)A study by Nahar et al showed cord bilirubin level >2.5 mg/dl had a sensitivity of 77%, specificity of 98.6% with negative predictive value of 96%.(10)STUDY JUSTIFICATION?Hyperbilirubinemia is one of the most common cause for readmission in newborns.?Only fewer tests are there to predict the accurence of hyperbilirubinemia in healthy neonates.?Mostly no investigations are utilised in a hospital setting as a predictor for hyperbilirubinemia leading to delay in diagnosis.?There are fewer Indian studies on the correlation between umblical cord blood albumin and occurrence of significant hyperbilirubinemia.REFERENCES 1. Bryon JL, Nancy DS. Hyperbilirubinemia in the newborn. Pediatrics in Review. 2011:32(8):341-9.2. Sgro M, Campbell D, Shah V. Incidence and causes of severe neonatal hyperbilirubinemia in Canada. CMAJ. 2006;175(6):587-90.3. Pahuja M, Dhawan S, Chaudhary SR. Correlation of cord blood bilirubin and neonatal hyperbilirubinemia in healthy newborns. Int J Contemp Pediatr. (2016);3(3):926-30.4. American Academy of Pediatrics Subcommittee onHyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatr. 2004;114(1):297-316.5. Taksande A, Vilhekar K, Jain M, Zade P, Atkari S, Verkey S. Prediction of the development of neonatal hyper Bilirubinemia by increased umbilical cord blood Bilirubin. Ind Medica. 2005;9(1):5-9.6. Sahu S, Abraham R, John J, Mathew AA. Cord blood albumin as a predictor of neonatal jaundice. Int J Biol Med Res. 2011;2(1):436-8.7. Trivedi DJ, Markande DM, Vidya BU, Bhat M, Hegde PR. Cord serum bilirubin and albumin in neonatal hyperbilirubinemia. Int J Int Sci Inn Tech Sec. 2013;2(2):39-42.8. Bunt JE, Rietveld T, Schierbeek H, Wattimena JL, Zimmermann LJ, van Goudoever JB. Albumin synthesis in preterm infants on the first day of life studied with 1-13C leucine. Am J Physiol Gastrointest Liver Physiol. 2007;292(4):1157-61.9. George NA, Sudhir MKS. To study the effectiveness of cord blood Albumin as a predictor of neonatal jaundice. Int J Contemp Pediatr 2017;4:645-8.10. Meena K J, Singh S, Verma R C, Sharma R. Utility of Cord Blood Albumin as a Predictor of Significant Neonatal Jaundice in Healthy Term Newborns. Pediatric Oncall [serial online] 2015[cited 2015 October-December 1];12.PROFORMABasic detailsName:OP number:Sex:Gestational age: Mode of delivery:Birth weight:Investigations Umblical cord blood albumin:Followed up details of hyperbilirubinemia and treatment givenINFORMED CONSENT FORMStudy title : A STUDY ON THE EFFECTIVENESS OF UMBLICAL CORD BLOOD ALBUMIN AS A PREDICTOR OF NEONATAL HYPERBILIRUBINEMIA IN HEALTHY NEONATES.Place of study: Department of Pediatrics,Southern Railway Headquarters Hospital,Perambur Name of Investigator : Dr. Shobana GName of Participant : Age: Sex: Hospital No: 1. I have read and understood this consent form and the information provided to me regarding the participation in the study.2. I have had the consent document explained to me. 3. I have been explained about the nature of the study.4. I have been explained about my rights and responsibilities by the investigator.5. I will allow my child to undergo blood tests and X-Ray during the study whole heartedly. 6. I have Informed the investigator of all the treatments I am taking or have taken in the past including any native (alternative) treatment.7. I have been advised about the risks associated with my participation in this study.8. I agree to cooperate with the investigator and I will inform him/her immediately if I suffer unusual symptoms.9. I have not participated in any research study in the past. 10. I am aware of the fact that I can opt out of the study at any time without having to give any reason and this will not affect my future treatment in this hospital. 11. I am also aware that the investigator may terminate my participation in the study at any time, for any reason, without my consent.12. I hereby give permission to the investigators to release the information obtained from me as result of participation in this study to the sponsors, regulatory authorities, Government Agencies, and IEC. I understand that they are publicly presented. 13. I have understood that my identity will be kept confidential if my data are publicly presented. 14. I have had my questions answered to my satisfaction.15. I have decided to be in the research study. I am aware that if I have any question during this study, I should contact the investigator. By signing this consent form I attest that the information given in this document has been clearly explained to me and understood by me, I will be given a copy of this consent document. Name and signature/thumb impression of the parents/guardian : Name : ____________________________ Signature : ___________________ Date : ____________Name and signature of impartial witness :Name : ____________________________ Signature : ___________________ Date : ____________Name and signature of the investigator or his representative obtaining consent : Name : ____________________________ Signature : ___________________ Date : ___________ ................
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