Ursodeoxycholic acid plus continuous triple phototherapy for newborn indirect jaundice
A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia
This trial will test whether adding oral ursodeoxycholic acid to continuous triple phototherapy helps newborns (≥34 weeks) with indirect hyperbilirubinemia lower bilirubin faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 1 Month |
| Sex | All |
| Sponsor | Tishreen University Hospital Academic / other |
| Locations | 1 site (Latakia) |
| Trial ID | NCT07110987 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, randomized controlled trial at Lattakia University Hospital randomizing neonates ≥34 weeks and appropriate for gestational age who meet AAP phototherapy thresholds to either continuous triple phototherapy alone or the same phototherapy plus oral UDCA (10 mg/kg/day in two doses). Randomization is stratified by jaundice etiology (hemolytic, non-hemolytic, and G6PD deficiency) using block methods. Total serum bilirubin is measured every 12 hours and the primary outcome is time until bilirubin falls below the age-specific AAP phototherapy threshold; secondary outcomes include bilirubin decline at 24 and 48 hours, need for rescue therapy, and subgroup analyses by gestational age and jaundice type. The intervention uses locally available Ursorasha and follows inpatient monitoring until discharge.
Who should consider this trial
Good fit: Ideal candidates are neonates born at ≥34 weeks gestation who are appropriate for gestational age and meet AAP criteria for phototherapy, without sepsis, significant liver disease, or TPN.
Not a fit: Infants born before 34 weeks, those who are small or large for gestational age, have conjugated hyperbilirubinemia, suspected sepsis, maternal diabetes, existing liver disease, or are receiving TPN are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding UDCA could shorten phototherapy duration and speed bilirubin clearance, potentially reducing hospital stay and need for additional interventions.
How similar studies have performed: Using UDCA for neonatal indirect hyperbilirubinemia is relatively novel with limited randomized evidence, though small observational reports have suggested potential benefit for bilirubin metabolism.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Neonates with gestational age ≥ 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)
Where this trial is running
Latakia
- Lattakia University Hospital — Latakia, Syria (Recruiting)
Study contacts
- Study coordinator: Ashraf M Alshelly, MD, Ped.Res.
- Email: Ashraf.m.alshelly@latakia-univ.edu.sy
- Phone: +963930052903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.