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Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates

NCT07774741 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-19

No results posted yet for this study

Summary

This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg/kg) and phenobarbitone (3 mg/kg) as adjuncts to conventional phototherapy in neonates with unconjugated hyperbilirubinemia. The study aims to compare their effectiveness in reducing total serum bilirubin. Secondary outcomes include duration of phototherapy, length of hospital stay, and treatment-related adverse effects.

Conditions

  • Jaundice, Neonatal

Interventions

DRUG

Fenofibrate + Phototherapy

Participants randomized to the experimental group will receive a single oral dose of fenofibrate in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.

DRUG

Phenobarbitone + Phototherapy

Participants randomized to the active comparator group will receive oral phenobarbitone in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.

Sponsors & Collaborators

  • Sheikh Zayed Medical College

    collaborator OTHER_GOV

  • Rubab Fatima

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2027-10-31

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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 NCT07774741 on ClinicalTrials.gov