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Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Primary Purpose

Neonatal Jaundice

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fenofibrate
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Neonatal Jaundice focused on measuring Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy

Eligibility Criteria

undefined - 28 Days (Child)All Sexes

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    GROUP1

    GROUP2

    GROUP3

    Arm Description

    group receiving single dose fenofibrate

    group receiving double dose fenofibrate

    photo therapy only

    Outcomes

    Primary Outcome Measures

    Total serum bilirubin
    measure level of serum total bilirubin (mg/dl)
    Total serum bilirubin
    measure level of serum total bilirubin (mg/dl)
    Total serum bilirubin
    measure level of serum total bilirubin (mg/dl)

    Secondary Outcome Measures

    length of hospital stay
    Duration of hospital admission (days)
    duration of photo therapy
    duration of photo therapy (hours)

    Full Information

    First Posted
    May 29, 2020
    Last Updated
    June 2, 2020
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04418180
    Brief Title
    Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
    Official Title
    Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    December 12, 2018 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Jaundice
    Keywords
    Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP1
    Arm Type
    Active Comparator
    Arm Description
    group receiving single dose fenofibrate
    Arm Title
    GROUP2
    Arm Type
    Active Comparator
    Arm Description
    group receiving double dose fenofibrate
    Arm Title
    GROUP3
    Arm Type
    Placebo Comparator
    Arm Description
    photo therapy only
    Intervention Type
    Drug
    Intervention Name(s)
    Fenofibrate
    Intervention Description
    Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    oral distilled water
    Primary Outcome Measure Information:
    Title
    Total serum bilirubin
    Description
    measure level of serum total bilirubin (mg/dl)
    Time Frame
    24 hours of treatment
    Title
    Total serum bilirubin
    Description
    measure level of serum total bilirubin (mg/dl)
    Time Frame
    48 hours of treatment
    Title
    Total serum bilirubin
    Description
    measure level of serum total bilirubin (mg/dl)
    Time Frame
    72 hours of treatment
    Secondary Outcome Measure Information:
    Title
    length of hospital stay
    Description
    Duration of hospital admission (days)
    Time Frame
    expected 3 days of treatment
    Title
    duration of photo therapy
    Description
    duration of photo therapy (hours)
    Time Frame
    expected 48 hours of treatment

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    28 Days
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33070152
    Citation
    Awad MH, Amer S, Hafez M, Nour I, Shabaan A. "Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.". J Perinatol. 2021 Apr;41(4):865-872. doi: 10.1038/s41372-020-00861-2. Epub 2020 Oct 17.
    Results Reference
    derived

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    Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

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