A Randomized Controlled Trial of Minimization of Intralipid Versus Omegaven for the Treatment of Severe Cholestasis- A Pilot Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.
详细描述
Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises >100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants admitted to neonatal intensive care unit
- •severe cholestasis, defined as conjugated bilirubin greater than 35
- •receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
- •signed consent
排除标准
- •hepatitis (TORCH or other viral infection)
- •primary liver disease as etiology of cholestasis
- •clinically severe bleeding not able to be managed with routine measures
- •lethal congenital abnormalities
- •congenital heart disease associated with right heart dysfunction
结局指标
主要结局
Feasibility
时间窗: up to 1 year
"Success" of the pilot trial will be determined by reaching the following criteria: 98.5% of subjects receive the modified lipid therapy within 12 to 24h of randomization; and/or 90% of subjects had their labs taken at the appropriate times as detailed by the study protocol.
Clinical endpoint
时间窗: up to 1 year
The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization
次要结局
- Total duration of parenteral nutrition(up to 1 year)
- Growth(up to 1 year)