The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
Recruiting now · Not applicable
Conditions studied: Hyperbilirubinemia, Neonatal Indirect
In brief
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.
Key facts
- Study ID
- NCT07110987
- Run by
- Tishreen University Hospital
- People needed
- 70
- Starts
- 2025-06-26
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Neonates with gestational age ≥ 34 weeks
- Appropriate for Gestational Age (AGA) infants
- Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
You may not qualify if…
- Gestational age < 34 weeks
- Small or Large for Gestational Age
- Direct (conjugated) hyperbilirubinemia > 20% of total bilirubin
- Suspected or confirmed sepsis
- Neonates of diabetic mothers
- Presence of congenital or acquired liver disease
- Receiving Total Parenteral Nutrition (TPN)
Where it is running
- Lattakia University Hospital — Latakia, Syria (enrolling)
Full record on ClinicalTrials.gov
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