Effect of ursodeoxycholic acid in unconjugated hyperbilirubinemia in the term neonates treated with phototherapy.

Abstract

Background Neonatal hyperbilirubinemia affects 60-80% of term neonates in the first week of life, with phototherapy (PT) being the standard treatment. However, prolonged PT has limitations, leading to the exploration of adjuvant therapies such as Ursodeoxycholic Acid (UDCA) to enhance bilirubin clearance. Objective To evaluate the efficacy and safety of UDCA as an adjunct to PT in term neonates with unconjugated hyperbilirubinemia (UCHB) by comparing bilirubin reduction, phototherapy duration, and hospital stay between neonates receiving UDCA + PT versus PT alone. Methods A randomized controlled study was conducted on 100 term neonates, divided into: • Group 1 (UDCA + PT, n = 50) receiving oral UDCA (10–15 mg/kg/day) with PT. • Group 2 (PT-only, n = 50) receiving standard PT alone. Total serum bilirubin (TSB) levels were measured at admission, 24 hours, and 48 hours. Phototherapy duration, NICU stay, and adverse effects were analyzed. Statistical analysis was performed using SPSS software, with p < 0.05 considered significant. Results The baseline characteristics were comparable between both groups (p > 0.05). The TSB decline at 48 hours was 9.3 ± 1.75 mg/dL in the UDCA + PT group versus 9.8 ± 1.9 mg/dL in the PT-only group (p = 0.175). The mean phototherapy duration was 47.84 ± 2.5 hours in the UDCA group and 48.22 ± 5.5 hours in the control group (p = 0.66). The mean NICU stay was 3.02 ± 0.24 days in the UDCA group and 3.0 ± 0.2 days in the PT-only group (p = 0.651).UDCA was well tolerated, with only 3 neonates experiencing mild vomiting, and no cases of diarrhea or metabolic disturbances reported. Conclusion UDCA may modestly enhance bilirubin clearance, but the observed differences in bilirubin reduction, phototherapy duration, and NICU stay were not statistically significant. Given its favorable safety profile, further large-scale randomized controlled trials (RCTs) are needed to confirm UDCA's role as a routine adjunct in neonates.