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

Manijeh Tabrizi1, Sadroddin Mahdipour1, Seyyedeh Azade Hoseini Nouri1

  • 1Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.

Iranian Journal of Medical Sciences
|May 8, 2026
PubMed

Insights

Ursodeoxycholic acid (UDCA) did not significantly lower bilirubin levels in infants with prolonged indirect hyperbilirubinemia (PIH). Further research is needed to explore UDCA

Area of Science:

  • Neonatal Medicine
  • Pediatric Gastroenterology
  • Pharmacology

Background:

  • Prolonged indirect hyperbilirubinemia (PIH) affects term infants for over 14 days and preterm infants for over 21 days.
  • Limited evidence exists on ursodeoxycholic acid (UDCA) as an adjunct therapy for PIH.
  • Investigating UDCA's efficacy in PIH is crucial for improving neonatal care.

Purpose of the Study:

  • To evaluate the effect of UDCA as an adjunct therapy in infants diagnosed with PIH.
  • To determine if UDCA administration can reduce elevated bilirubin levels in term and preterm infants.

Main Methods:

  • A randomized controlled trial conducted in Rasht, Iran, from July 2023 to July 2024.
  • Infants with PIH were randomly assigned to receive 10 mg/Kg/day UDCA for 5 days or no intervention.
  • Bilirubin levels, ABO, and Rh blood group status were measured on days 1 and 5; data analyzed using independent samples t-test.

Main Results:

  • Both groups showed significant bilirubin reduction over 5 days (P<0.001).
  • No statistically significant difference in mean bilirubin reduction was observed between the UDCA intervention group (2.89±3.00 mg/dL) and the control group (2.17±2.50 mg/dL; P=0.323).
  • ABO incompatibility was linked to lower day 5 bilirubin in the UDCA group (P=0.041), and Rh incompatibility to greater bilirubin reduction (P=0.025).

Conclusions:

  • A 5-day course of UDCA therapy did not demonstrate a significant reduction in bilirubin levels for infants with PIH.
  • The study suggests UDCA may not be an effective adjunct treatment for PIH under the tested conditions.
  • Further investigation into UDCA's role in neonatal hyperbilirubinemia is warranted.
Abstract

Keywords:
HyperbilirubinemiaInfantJaundicePhototherapyUrsodeoxycholic acid

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