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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP1 | Active Comparator | group receiving single dose fenofibrate |
|
| GROUP2 | Active Comparator | group receiving double dose fenofibrate |
|
| GROUP3 | Placebo Comparator | photo therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33070152 | Derived | 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. |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | oral distilled water |
|
| expected 48 hours of treatment |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |