Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- Total serum bilirubin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GROUP3
photo therapy only
干预措施: Placebo (Drug)
GROUP1
group receiving single dose fenofibrate
干预措施: Fenofibrate (Drug)
GROUP2
group receiving double dose fenofibrate
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Total serum bilirubin
时间窗: 72 hours of treatment
measure level of serum total bilirubin (mg/dl)
次要结局
- length of hospital stay(expected 3 days of treatment)
- duration of photo therapy(expected 48 hours of treatment)
研究者
Abd Elazeez Attala Shabaan
Professor
Mansoura University