Objective: To evaluate efficacy of predischarge transcutaneous bilirubin (TcB) measurement and clinical risk assessment in predicting hyperbilirubinemia needing treatment.Study Design: A diagnostic test was performed in a prospective cohort study conducted at a teaching hospital in North India. Subjects included healthy neonates with a gestation period of X35 weeks or birth weight X2000 g. Maternal, neonatal and delivery risk factors for hyperbilirubinemia were prospectively collected. TcB was measured in all enrolled neonates at 24±6, 72 to 96 and 96 to 144 h of postnatal age and when indicated clinically. Neonates were followed up during hospital stay and after discharge till completion of the 7th postnatal day. The key outcome was significant hyperbilirubinemia defined as need of phototherapy on the basis of modified American Academy of Pediatrics guidelines. In neonates born at X38 weeks of gestation and in neonates born at p37 completed weeks of gestation, middle line and lower line of phototherapy thresholds were used to initiate phototherapy, respectively. Variables observed to be significantly associated with significant hyperbilirubinemia on multivariate analysis were used for construction of a clinical risk assessment tool. Predictive ability of the risk assessment tool was assessed by calculating sensitivity, specificity, positive predictive value and negative predictive value, by plotting receiver-operating characteristics curve and calculating c-statistic.Result: A total of 997 neonates (birth weight: 2627 ± 536 g, gestation: 37.8 ± 1.5 weeks) were enrolled in the study, of which 931 completed follow-up. Among enrolled neonates, 344 (34.5%) were low birth weight. Overall, a total of 199 (20%) neonates developed significant hyperbilirubinemia. On stepwise logistic regression analysis, predischarge TcB percentile and gestation were significantly found to be associated with significant hyperbilirubinemia. A risk assessment graph was constructed to predict subsequent development of significant hyperbilirubinemia. Area under curve for this risk assessment strategy was 0.75.
Conclusion:A risk assessment graphical tool consisting of TcB and gestation accurately predicted subsequent need of phototherapy. Further studies are needed to validate performance of this risk assessment tool.