Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Resolution of Cholestasis for Subjects Who Received Omegaven
研究概览
简要总结
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
详细描述
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.
Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Live in or temporarily relocate to Oklahoma
- •Age less than 18 years, both sexes, all races
- •Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
- •Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
- •Are not currently enrolled in another lipid emulsion study
排除标准
- •Known food allergy to fish
- •Known metabolic disorder of lipid metabolism
- •Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
- •Medical condition likely to result in death in the next 30 days
研究组 & 干预措施
Omegaven
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
干预措施: Omegaven (Drug)
结局指标
主要结局
Resolution of Cholestasis for Subjects Who Received Omegaven
时间窗: Within the first 3 months of sole Omegaven use
To determine if Omegaven results in the resolution of cholestasis (DB \<2 for 2 consecutive weeks)
次要结局
- Safety Issues for Infants Who Received Omegaven(Within the first year of use)
- Essential Fatty Acid Deficiency in Infants Who Received Omegaven(Within the first month of use)