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