THE IMPACT OF URSODEOXYCHOLIC ACID ON UNCONJUGATED HYPERBILIRUBINEMIA IN TERM NEONATES UNDERGOING PHOTOTHERAPY

Abstract

Background: Neonatal jaundice affects approximately 60% of term newborns. Unconjugated hyperbilirubinemia is primarily managed with phototherapy, which carries risks including mother–infant separation, dehydration, and skin rash. Ursodeoxycholic acid (UDCA), a hydrophilic bile acid with an established safety profile in pediatric cholestatic liver disease, may enhance bilirubin elimination by reducing enterohepatic circulation and providing hepatoprotection.

Objectives: To evaluate whether adjunctive oral UDCA combined with phototherapy accelerates bilirubin clearance in term neonates with unconjugated hyperbilirubinemia compared to phototherapy alone.

Methods: This randomized controlled trial was conducted at the Department of Paediatrics, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan, Pakistan (December 2024–May 2025). Seventy-six term neonates (≥37 weeks) with non-hemolytic indirect hyperbilirubinemia were randomized 1:1 to intensive phototherapy plus oral UDCA 10 mg/kg/day (n=38) or phototherapy alone (n=38). Total serum bilirubin (TSB) was measured at baseline and at 24, 48, and 72 hours.

Results: Baseline characteristics were comparable between groups. The UDCA group demonstrated significantly greater TSB reduction at 72 hours (8.5 ± 1.5 vs. 7.0 ± 1.8 mg/dL; p<0.001; mean difference 1.4 mg/d

L; 95% CI: 0.89–1.91) and shorter phototherapy duration (30.4 ± 6.2 vs. 42.1 ± 7.5 hours; p<0.001). More UDCA-treated infants achieved TSB <10 mg/dL by 48 hours (79% vs. 50%; p=0.003). No adverse effects were observed in either group.

Conclusions: Adjunctive UDCA significantly accelerated bilirubin reduction and shortened phototherapy duration in term neonates without adverse effects. These findings support UDCA as a potentially safe and effective supplement to phototherapy in neonatal unconjugated hyperbilirubinemia, though confirmation by larger multicentre trials is warranted.