Evaluating the Etiology of Prolonged Unconjugated Hyperbilirubinemia in Term Neonates admitted to Neonatal Wards: A Randomized Controlled Trial

Abstract

Background: The Jaundice, also known as hyperbilirubinemia, is a potentially fatal condition that affects neonates. Several different factors contribute to this complex illness. Objective: The objective of this study was to compare the mean duration of phototherapy in neonates with indirect hyperbilirubinemia treated with ursodeoxycholic acid plus phototherapy versus phototherapy alone. Study Design: Randomized Controlled Trial (RCT) study design. Settings: This study was carried at Department of Pediatrics Shahida Islam Medical College, Lodhran Pakistan. Duration: Over 1 year from March 2020 to March 2021. Methods: Seventy full-term babies of both sexes were randomly split into two groups. Indirect hyperbilirubinemia was the diagnosis for all the infants, and phototherapy was being used to treat the condition. The patients in Group-A also received Ursodeoxycholic acid in addition to the phototherapy, while those in Group-B received only the phototherapy. Results: The average age of the newborns was 4.77 ± 3.05 days. There were a total of 50 newborns, 49 boys (or 70%) and 21 girls (or 30%). The indirect bilirubin levels of the newborns varied between 8.3 and 13.6 mg/dl, with a mean of 10.731.61 mg/dl. The survival rate of newborns treated with ursodeoxycholic acid and phototherapy was significantly higher than that of neonates treated with phototherapy alone (20.60 ± 4.24 vs. 43.34 ± 4.56 hours; p0.001). Conclusion: Due to its low cost, ease of administration, and better safety profile, the addition of ursodeoxycholic acid significantly decreased the mean duration of phototherapy in neonates presenting with jaundice, which supports the preferred use of this novel agent in the management of such neonates in future practice.