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 ۸۴% 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 ۱۰mg/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 ۱۲ hours, and the groups were compared regarding the reduction duration of bilirubin <۱۰ mg/dl and the duration of phototherapy. Data analysis used SPSS-V۲۲ software, with statistical tests done at a significance level of <۰.۰۵. Results: In total, ۱۲۸ neonates, comprising ۵۶ (۴۳.۸%) males and ۷۲ (۵۶.۲%) females, with a mean gestational age of ۳۹.۰۲±۰.۸۶ weeks and a mean age of ۲.۷۷±۱.۴۵ days, were subjected to analysis. After ۹۶ hours, the mean bilirubin level was ۹.۲۳±۲.۸۱ mg/dl overall, ۷.۲۷±۲.۱۲ mg/dl in the case group, and ۱۰.۹۱±۲.۱۷ mg/dl in the control group (p<۰.۰۰۱). The mean time to reach a bilirubin level below ۱۰ mg/dl was ۵۱.۶۶±۱۷.۲۷ hours overall, ۵۸.۳۸±۱۰.۰۵ hours for the case group, and ۶۲.۶۱±۱۴.۳۹ hours for the control group (p<۰.۰۰۱). 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.

کلیدواژه ها:

Hyperbilirubinemia ، Jaundice ، Phototherapy ، Ursodeoxycholic acid