Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

The University of Texas Health Science Center at San Antonio1 个研究点分布在 1 个国家开始时间: 2011年8月30日最近更新: 2019年2月12日

适应症

试验速览

阶段: 不适用
状态: Approved For Marketing
发起方: The University of Texas Health Science Center at San Antonio
试验地点: 1

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

详细描述

Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 14 Days 至 24 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

•Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish

研究者

发起方

The University of Texas Health Science Center at San Antonio

申办方类型

Other

责任方

Sponsor

研究点 (1)

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