Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Total serum bilirubin [24 hours of treatment]
measure level of serum total bilirubin (mg/dl)
- Total serum bilirubin [48 hours of treatment]
measure level of serum total bilirubin (mg/dl)
- Total serum bilirubin [72 hours of treatment]
measure level of serum total bilirubin (mg/dl)
Secondary Outcome Measures
- length of hospital stay [expected 3 days of treatment]
Duration of hospital admission (days)
- duration of photo therapy [expected 48 hours of treatment]
duration of photo therapy (hours)
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MansouraU003