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

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.