Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Drug: Fenofibrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum bilirubin | measure level of serum total bilirubin (mg/dl) | 24 hours of treatment | 
| Total serum bilirubin | measure level of serum total bilirubin (mg/dl) | 48 hours of treatment | 
| Total serum bilirubin | 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 | Duration of hospital admission (days) | expected 3 days of treatment | 
| duration of photo therapy | duration of photo therapy (hours) | expected 48 hours of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy