NCT02534077Approved For Marketing不适用
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- Pediatrix
- 试验地点
- 1
研究概览
简要总结
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
详细描述
Compassionate Use
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 14 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.
- •Be expected to require intravenous nutrition for at least an additional 28 days
- •Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:
- •Reduction of Intralipid® to 1 g/kg/day
- •Limiting trace minerals including copper and manganese
- •Initiation and use of Ursodiol
- •Cycling of parenteral nutrition
- •Advancement of enteral feedings
- •Parental informed consent must be signed.
排除标准
- •Have a congenitally lethal condition (e.g. Trisomy 13).
- •Have clinically severe bleeding not able to be managed with routine measures.
- •Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
- •Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
- •Has culture positive sepsis
研究者
研究点 (1)
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