Cholestasis Prevention: Efficacy of IV Fish Oil
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Presence vs. absence of PN-associated cholestasis (PNAC)
研究概览
简要总结
Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure
详细描述
We propose to conduct a randomized controlled clinical trial to determine whether the use of an omega-3 fatty acid based IFE in infants with surgical gastrointestinal disease will improve clinical outcomes compared to infants treated with standard IFE up to 6 months post randomization. Neonates and infants < 3 months old (postnatally) with surgical gastrointestinal disease (defined as congenital or acquired gastrointestinal disease requiring PN for more than 21 days) will be eligible for enrollment. Patients who meet all inclusion and exclusion criteria will be randomized to receive PN with either Intralipid® or Omegaven®. The appearance of both IFEs is indistinguishable, so patients, families and the medical care team will be blinded to treatment group allocation. Aside from the IFE type, the clinical care of both groups of infants will remain unchanged, including standard use of feeding advancement protocols, and treatment of underlying gastrointestinal and other diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omegaven
Omegaven is a fish based intravenous fat emulsion
干预措施: Omegaven (Drug)
Intralipid
干预措施: Intralipid (Drug)
结局指标
主要结局
Presence vs. absence of PN-associated cholestasis (PNAC)
时间窗: 6 months
The definition of "Presence vs. Absence of PNAC" will vary with the post conceptual age of the child. In infants \> 40 weeks post conceptual age, we will define PN-associated cholestasis as four consecutive measurements (\> 6 days apart) of serum direct bilirubin \> 2.0mg/dL obtained over a 30 day period in the absence of other demonstrable etiologies of cholestasis. Due to hepatic immaturity, for infants \< 40 weeks post conceptual age, PN associated cholestasis will be defined as four consecutive measurements (\> 6 days apart) of serum direct bilirubin \> 2.0mg/dL obtained over a 42 day period.
次要结局
- Incidence and severity of ROP(6 months)
- Fatty acid profiles(6 months)
- Weight and height gain(6 months)
- Liver function tests(6 months)
- Death from PNALD liver or liver/gastrointestinal tract transplant.(1 year)
- Duration of parenteral nutrition(6 months)
- Frequency of blood stream infections(6 months)
- Inflammatory markers (C-reactive protein), cytokine levels(6 months)
- Neurodevelopment Assessments(6, 12, & 24 months (corrected for gestational age))
研究者
Mark Puder
Medical Staff
Boston Children's Hospital