Ursodeoxycholic Acid in the Management of Prolonged Neonatal Hyperbilirubinemia: A Randomized Controlled Clinical Trial.

Abstract

Background: Prolonged indirect hyperbilirubinemia (PIH) is defined as bilirubin levels >10 mg/dL for more than 14 days in term infants and 21 days in preterm infants. Although the role of ursodeoxycholic acid (UDCA) as an adjunct to phototherapy has been evaluated, evidence in PIH remains limited. Therefore, this study aimed to investigate the effects of UDCA on PIH.

Methods: This randomized controlled trial was conducted on infants with PIH in Rasht, Iran, (July 2023-July 2024). Participants were enrolled through consecutive sampling and randomly assigned to intervention or control groups. The intervention group received 10 mg/Kg/day UDCA for 5 days. The control group received no intervention and was observed. Bilirubin, ABO, and Rh blood group status were measured on day 1 and day 5. Data were analyzed using an independent samples t test with SPSS software (version 26). P<0.05 was considered statistically significant.

Results: Fifty-eight patients were included, with 29 in each group. Both groups showed a significant reduction in bilirubin levels over 5 days (control: 12.26±1.65 to 10.09±2.74 mg/dL; intervention: 11.96±1.48 to 9.07±3.45 mg/dL; P<0.001). The mean bilirubin reduction was 2.17±2.50 mg/dL in the control group and 2.89±3.00 mg/dL in the intervention group, with no statistically significant difference between groups (P=0.323). On day 5, bilirubin levels were 10.09±2.74 mg/dL in the control group and 9.07±3.45 mg/dL in the intervention group (P=0.216). ABO incompatibility was associated with lower bilirubin levels on day 5 in the intervention group (7.26±2.33 vs. 9.76±3.61 mg/dL; P=0.041). Rh incompatibility was correlated with greater bilirubin reduction over 5 days (4.98±1.54 vs. 2.45±3.07 mg/dL; P=0.025).

Conclusion: Five-day UDCA therapy did not significantly reduce bilirubin levels in infants with PIH.Trial Registration Number: IRCT 2018.228.38895N2.