NCT01601652已完成1 期
Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Arthur J De Lorimier1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
研究概览
简要总结
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
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 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cholestasis defined as either
- •serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
- •serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
排除标准
- •Age > 1y at time that omegaven is started
- •Not expected to survive at least 30 days
- •Fish allergy in a first degree relative
- •Hemodynamic instability
- •Coagulopathy
- •Not likely to require PN for > 30d
- •Not expected to survive > 30d
研究组 & 干预措施
Omeagven
Experimental
干预措施: Omegaven (Drug)
结局指标
主要结局
Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)
时间窗: approximately for 4 months
次要结局
- Liver Transaminases(approximately for 4 months)
研究者
Arthur J De Lorimier
Associate Professor of Pediatrics
University of California, Davis
研究点 (1)
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