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OpenTrials
Completed

NCT Number: NCT04418180

Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

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.

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Key information

Conditions

Neonatal Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate

Drug

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

Placebo

Drug

oral distilled water

Primary outcomes

  1. Total serum bilirubin

    Time frame: 24 hours of treatment

    measure level of serum total bilirubin (mg/dl)

  2. Total serum bilirubin

    Time frame: 48 hours of treatment

    measure level of serum total bilirubin (mg/dl)

  3. Total serum bilirubin

    Time frame: 72 hours of treatment

    measure level of serum total bilirubin (mg/dl)

Secondary outcomes

  1. length of hospital stay

    Time frame: expected 3 days of treatment

    Duration of hospital admission (days)

  2. duration of photo therapy

    Time frame: expected 48 hours of treatment

    duration of photo therapy (hours)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
First posted
Jun 5, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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