The Impact of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Infants Treated with Photo-therapy: A Single-Blind Randomized Clinical Trial

Document Type : Original Article

Authors

1 Neonatal and Children’s Health Research Center, Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran

2 Neonatal and Children’s Health Research Center , Golestan University of Medical Sciences, Gorgan, Iran

3 Neonatal and Children and rsquo, Health Research Center, Clinical Research Development Unit (CRDU), Sayad Shirazi Hospital Golestan University of Medical Sciences, Gorgan, Iran Golestan University of Medical Sciences, Gorgan, Iran

Abstract

Background: Infantile jaundice affects up to 84% of term infants and is a primary cause of re-hospitalization. Phototherapy, the primary therapeutic intervention, may be associated with several complications. Therefore, employing additional compensatory therapies could reduce the duration of phototherapy and its adverse effects.
Methods: A single-blind randomized clinical trial was conducted on newborns with indirect hyperbilirubinemia (IHB) undergoing phototherapy. Patients were randomly assigned to two groups: the intervention group received phototherapy and 10mg/kg of Ursodeoxycholic acid, taken twice a day with water as the solvent, while the control group received phototherapy and a placebo (water). Total bilirubin levels were measured every 12 hours, and the groups were compared regarding the reduction duration of bilirubin <10 mg/dl and the duration of phototherapy. Data analysis used SPSS-V22 software, with statistical tests done at a significance level of <0.05.
Results: In total, 128 neonates, comprising 56 (43.8%) males and 72 (56.2%) females, with a mean gestational age of 39.02±0.86 weeks and a mean age of 2.77±1.45 days, were subjected to analysis. After 96 hours, the mean bilirubin level was 9.23±2.81 mg/dl overall, 7.27±2.12 mg/dl in the case group, and 10.91±2.17 mg/dl in the control group (p<0.001). The mean time to reach a bilirubin level below 10 mg/dl was 51.66±17.27 hours overall, 58.38±10.05 hours for the case group, and 62.61±14.39 hours for the control group (p<0.001).
Conclusion: Ursodeoxycholic acid (UDCA) effectively reduces elevated bilirubin levels and the duration of phototherapy when employed as an adjunct treatment to phototherapy in cases of infantile indirect hyperbilirubinemia.
 

Keywords

References

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Iranian Journal of Neonatology
Volume 15, Issue 4
October 2024
Pages 17-23

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