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This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation.
Eligible neonates will be randomly assigned to one of two groups:
Group A: continuous triple phototherapy only
Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy.
Stratified randomization will be applied according to etiology (hemolytic, non-hemolytic, G6PD deficiency). The primary outcome is the rate and time of decline in total and indirect serum bilirubin to below phototherapy thresholds, monitored every 12 hours until discharge.
This trial seeks to determine whether UDCA may reduce phototherapy duration or enhance bilirubin clearance in a safe and effective manner.
Although this is an open-label trial for care providers and participants , the statstican conducting data analysis will be blinded to group allocation to reduce assessment bias.
Full description
This is a prospective, open-label, randomized controlled clinical trial designed to assess the efficacy of ursodeoxycholic acid (UDCA) as an adjuvant to continuous triple phototherapy in neonates with indirect hyperbilirubinemia.
The study includes neonates ≥34 weeks gestational age and appropriate for gestational age (AGA), who meet the American Academy of Pediatrics (AAP) criteria for starting phototherapy.
Participants will be randomized 1:1 into two parallel arms:
Group A (Control): Continuous triple phototherapy
Group B (Intervention): Continuous triple phototherapy + oral UDCA at a dose of 10 mg/kg/day divided into two doses, using locally available Ursorasha (Rasha Pharma, license #1991/1192).
Randomization will be performed using stratified block randomization, with three stratification layers to balance known confounding factors across groups:
Total serum bilirubin (TSB) will be monitored every 12 hours and compared across groups. Primary outcome is the time needed for bilirubin to drop below phototherapy threshold, according to age-specific AAP phototherapy nomograms.
Additional secondary analyses will include the rate of bilirubin decline at 24 and 48 hours, need for rescue therapy, and subgroup analysis based on gestational age (late preterm vs term), and jaundice type.
Based on retrospective hospital data, the anticipated enrollment is 70 neonates. However, due to the lower prevalence of G6PD deficiency, this subgroup may not yield enough cases for statistically powered subgroup analysis. It will instead be analyzed descriptively or as exploratory.
The study includes clearly defined inclusion/exclusion criteria and a unified therapeutic protocol applied to all infants.
Inclusion criteria: Neonates ≥34 weeks GA, AGA, with indirect hyperbilirubinemia requiring phototherapy.
Exclusion criteria: Neonates <34 weeks, non-AGA, suspected/confirmed sepsis, TPN, liver disorders, or infants of diabetic mothers.
This protocol was initiated and registered within 21 days of enrolling the first patient. The study has received initial approval from the Department of Pediatrics at Lattakia University Hospital (formerly Tishreen University Hospital) under Committee Decision #70. Final administrative ethics approval from the university is in progress due to procedural delays in our country.
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70 participants in 2 patient groups
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Central trial contact
Ashraf M Alshelly, MD, Ped.Res.
Data sourced from clinicaltrials.gov
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