NCT02420496撤回2 期
Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo (?) for the Treatment of Cholestasis in Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Direct Bilirubin
研究概览
简要总结
To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who:
- •Are >14 days old and <24 months of age
- •Have a serum direct bilirubin of ≥2 mg/dL
- •Are receiving <3 g/k/day of Intralipid via TPN
- •Are expected to remain hospitalized for at least an additional 21 days
排除标准
- •Have a congenitally lethal condition (e.g. Trisomy 13)
- •Have clinically severe bleeding not able to be managed with routine measures
- •Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis
- •Have other health problems such that survival is extremely unlikely even if cholestasis improves
- •Known allergy to eggs or fish products
- •Receiving IV Fish oil
- •Phenobarbital therapy at enrollment
研究组 & 干预措施
Enteral fish oil
Experimental
Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally.
干预措施: Enteral fish oil (Drug)
UDCA (ursodeoxycholic acid)
Active Comparator
Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally
干预措施: Ursodeoxycholic Acid (Drug)
Placebo
Placebo Comparator
Infant will receive placebo in two daily doses given enterally
干预措施: Placebo (Drug)
结局指标
主要结局
Direct Bilirubin
时间窗: Evaluated every 7 days up to 180 days
Direct bilirubin less than 1 mg/dL considered resolution of cholestasis
次要结局
未报告次要终点
研究者
研究点 (1)
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