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

NCT07110987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Hyperbilirubinemia, Neonatal Indirect

Interventions

PROCEDURE

Phototherapy

Triple continuous phototherapy per AAP Guudelines

DRUG

ursodeoxycholic acid (UDCA)

10mg/kg/day orally divided in two doses (URSORASHA) . Given with feeds untill the bilirubin level drop down to limits that don't need therapy due to AAP guidelines.

Sponsors & Collaborators

  • Tishreen University Hospital

    lead OTHER

Principal Investigators

  • Adnan H Dayoub, Prof.Neonat · Lattakia university hospital (Tishreen university Hospital ) , Lattakia university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2027-01-15
Completion
2027-03-01

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110987 on ClinicalTrials.gov