Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants With Resolution of the Direct Hyperbilirubinemia
研究概览
简要总结
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil. There is a suggestion in the literature that using fish oil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.
详细描述
Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.
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 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants in the newborn intensive care unit
- •TPN cholestasis of at least 2.5 mg/dl
- •Anticipated TPN treatment for at least one month
- •signed informed consent
排除标准
- •Enrollment in another trial
- •Lack of consent
研究组 & 干预措施
Treatment
All infants will receive Omegaven
干预措施: Omegaven (Drug)
结局指标
主要结局
Number of Participants With Resolution of the Direct Hyperbilirubinemia
时间窗: At discharge or up to 10 weeks
Defined as direct bilirubin \<2.0 mg/dL
次要结局
未报告次要终点