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Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

NCT04418180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-06-05

No results posted yet for this study

Summary

Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions.

Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for treatment of pathological jaundice in full term infants.

Design/Methods: We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate.

Conditions

  • Neonatal Jaundice

Interventions

DRUG

Fenofibrate

Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr

DRUG

Placebo

oral distilled water

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2018-12-12

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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 NCT04418180 on ClinicalTrials.gov