Ursodeoxycholic acid plus continuous triple phototherapy for newborn indirect jaundice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.