ABSTRACT
Background: Hyperbilirubinemia is a common neonatal problem. Phototherapy and exchange transfusion is the conventional treatment for indirect hyperbilirubinemia. In the treatment of cholestatic liver disorders, Ursodeoxycholic acid (UDCA) is a bile acid widely used. Few studies have been conducted using UDCA in indirect hyperbilirubinemia. Aim of the study: This study was planned to assess the additive effect of UDCA on reducing indirect hyperbilirubinemia in neonates receiving phototherapy. Material & Methods:This prospective randomized controlled trial was conducted among neonates with indirect hyperbilirubinemia in the neonatal wards of Bangladesh Shishu Hospital and Institute, Dhaka, Bangladesh from June 2018 to July 2020. Finally, 140 neonates were included in the study. Eligible cases were randomized into two groups by the lottery method. Group A (n=70) received phototherapy and Group B (n=70) received UDCA at a dose of 10 mg/kg/day orally twice daily in addition to phototherapy. Total serum bilirubin levels were measured every 12 hours until serumbilirubinlevel falls below 10 mg/dl and then phototherapy was stopped. Demographic data, clinical features, laboratory parameters, outcome variables, and complications were recorded in a pre-format sheet. CBC with PBF, Total and indirect bilirubin, Blood grouping and Rh and typing, CRP, Reticulocyte count, and Coombs test were obtained at enrolment. Comparison of parameters among themselves was done by unpaired t-test and chi-square test. Analyzed outcomes were: time for resolution of jaundice, total duration of phototherapy, length of hospital stays, and adverse effects of the drug. The two groups did not differ statistically in age, sex or weight. The mean total serum bilirubin level measured at 12, 24, 36, 48, and 60 hours of treatment in group A was 16.10±1.43, 14.76±1.45, 13.34±1.68, 11.84±1.35, and, 10.57±0.74 respectively, and in the group, B was,15.18±1.63, 13.18±2.25, 11.39±1.56, 9.84±0.81 and, 9.44±0.46 respectively (p<0.001). The mean duration of phototherapy (64.11±10.8 vs. 47.18±7.51 hours, p<0.001) and length of hospital stay (2.80 ±0.40 vs. 2.19±0.39 days, p=<0.001).Conclusion:The inclusion of UDCA as an adjuvant to phototherapy is more effective in reducing indirect hyperbilirubinemia in neonates.