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

RecruitingNAAges any - 1 MonthAllTishreen University Hospital
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ34 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 clear

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Neonates with gestational age โ‰ฅ 34 weeks 2. Appropriate for Gestational Age (AGA) infants 3. Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy. Exclusion Criteria: 1. Gestational age \< 34 weeks 2. Small or Large for Gestational Age 3. Direct (conjugated) hyperbilirubinemia \> 20% of total bilirubin 4. Suspected or confirmed sepsis 5. Neonates of diabetic mothers 6. Presence of congenital or acquired liver disease 7. Receiving Total Parenteral Nutrition (TPN)
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What it tests

  • Phototherapy
  • ursodeoxycholic acid (UDCA)
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Where

1 site
Lattakia University Hospital
Latakia, Syria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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