Therapeutic Effects of Ursodeoxycholic Acid in Neonatal Indirect Hyperbilirubinemia: A Randomized Double-blind Clinical Trial

  • Iraj Shahramian Pediatric Ward, Zabol University of Medical Sciences, Zabol, Iran
  • Kaveh Tabrizian Department of Pharmacodynamics and Toxicology, School of Pharmacy, Zabol University of Medical Sciences, Zabol, Iran
  • Pouya Ostadrahimi School of Medicine, Zabol University of Medical Sciences, Zabol, Iran
  • Mahdi Afshari Department of Community Medicine, Zabol University of Medical Sciences, Zabol, Iran
  • Mahdieh Soleymanifar Research Committee, Zabol University of Medical Sciences, Zabol, Iran
  • Ali Bazi Clinical Research Development Unit, Amir-Al-Momenin Hospital, Zabol University of Medical Sciences, Zabol, Iran
Unconjugated hyperbilirubinemia, Ursodeoxycholic acid, Phototherapy


Background: Ursodeoxycholic acid (UDCA) is a safe drug used in the treatment of cholestatic liver disorders in children. The aim of this study was to investigate the synergistic effect of UDCA in combination with phototherapy in treating indirect neonatal hyperbilirubinemia.

Methods: Present double-blinded, randomized clinical trial was conducted among neonates with jaundice who were under treatment with phototherapy in the neonatal ward affiliated with the Zabol University of Medical Sciences in 2017. The patients (200 neonates) were randomly divided into intervention (phototherapy+ UDCA) and control (phototherapy alone) groups. The intervention group received 15 mg/kg UDCA daily.

Results: Total bilirubin levels at birth, 24, 48, and 72 hours after therapy were 16.89± 2.49, 14.28± 2.05, 11.62± 2.46, and 10.26± 1.92 mg/dl in controls and 15.79± 2.18, 12.77± 1.86, 10.08± 1.66, and 8.94± 1.38 mg/dl in intervention group respectively (P< 0.001). The ratio of neonates with total bilirubin< 10 mg/dl were 28% and 55% after 48 hours, and 64% and 90% after 72 hours of therapy initiation in phototherapy alone and phototherapy+ UDCA groups respectively (P< 0.001). The mean reduction of direct bilirubin was not significantly different between the groups.

Conclusion: UDCA was effective in accelerating reduction of total bilirubin level in neonates with unconjugated hyperbilirubinemia under phototherapy but had no effect on direct bilirubin levels.


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How to Cite
Shahramian I, Tabrizian K, Ostadrahimi P, Afshari M, Soleymanifar M, Bazi A. Therapeutic Effects of Ursodeoxycholic Acid in Neonatal Indirect Hyperbilirubinemia: A Randomized Double-blind Clinical Trial. Arch Anesth & Crit Care. 5(3):99-03.
Research Article(s)