Study of Ursodeoxycholic Acid UDCA with Phototherapy for Treating Neonatal Indirect Hyperbilirubinemia in Babies Born at 34 Weeks or Later

What this Trial Is About

Researchers are investigating the effect of Ursodeoxycholic Acid UDCA combined with triple phototherapy in treating indirect hyperbilirubinemia in newborns born at or after 34 weeks of gestation. This open-label, randomized controlled trial aims to see if adding UDCA can help lower bilirubin levels faster or reduce the time needed for phototherapy compared to phototherapy alone. The study is conducted at Lattakia University Hospital and includes stratification based on jaundice cause, such as hemolytic, non-hemolytic, or G6PD deficiency. Newborns meeting the criteria will be randomly assigned to one of two groups one receiving continuous triple phototherapy alone, and the other receiving the same phototherapy plus oral UDCA at 10 mg per kg per day split into two doses. The UDCA is given with feeding until bilirubin levels fall below the treatment threshold. Phototherapy follows American Academy of Pediatrics guidelines, and participants are monitored closely during treatment. Parents can expect their newborns to have bilirubin levels checked every 12 hours until discharge. The main measures are the time and rate at which bilirubin decreases below phototherapy thresholds within seven days. Secondary outcomes include hospital stay length, bilirubin reduction differences between late preterm and term infants, need for retreatment, and monitoring for any side effects in the UDCA group. The study continues until bilirubin normalizes or treatment ends, with follow-up up to 10 days after discontinuation.

The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia