Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

June 2, 2020 updated by: Abd Elazeez Attala Shabaan, Mansoura University

Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP1
group receiving single dose fenofibrate
Drug: Fenofibrate
Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
Active Comparator: GROUP2
group receiving double dose fenofibrate
Drug: Fenofibrate
Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
Placebo Comparator: GROUP3
photo therapy only
Drug: Placebo
oral distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total serum bilirubin
Time Frame: 24 hours of treatment
measure level of serum total bilirubin (mg/dl)
24 hours of treatment
Total serum bilirubin
Time Frame: 48 hours of treatment
measure level of serum total bilirubin (mg/dl)
48 hours of treatment
Total serum bilirubin
Time Frame: 72 hours of treatment
measure level of serum total bilirubin (mg/dl)
72 hours of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: expected 3 days of treatment
Duration of hospital admission (days)
expected 3 days of treatment
duration of photo therapy
Time Frame: expected 48 hours of treatment
duration of photo therapy (hours)
expected 48 hours of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MansouraU003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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