Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Not Applicable

Completed

• Conditions: Neonatal Jaundice
• Interventions: Drug: Placebo; Drug: Fenofibrate

• Registration Number: NCT04418180
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2018-12-12
• Study First Submitted: 2020-05-29
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Study First Posted: 2020-06-05
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines

Exclusion Criteria

• Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GROUP3	Placebo	photo therapy only
GROUP2	Fenofibrate	group receiving double dose fenofibrate
GROUP1	Fenofibrate	group receiving single dose fenofibrate

Primary Outcome Measures

Name	Time	Method
Total serum bilirubin	72 hours of treatment	measure level of serum total bilirubin (mg/dl)

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	expected 3 days of treatment	Duration of hospital admission (days)
duration of photo therapy	expected 48 hours of treatment	duration of photo therapy (hours)