Clinical Trial: Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
Brief Summary: The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Detailed Summary: Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
Sponsor: Children's Hospital Medical Center, Cincinnati
Current Primary Outcome: Reduction in Conjugated/Direct Bilirubin [ Time Frame: 14 weeks ]
Original Primary Outcome: Reduction in Conjugated Bilirubin [ Time Frame: 14 weeks ]
Current Secondary Outcome: Normalization of total bilirubin and liver enzymes [ Time Frame: 14 weeks ]
Original Secondary Outcome: Normalization of total bilirubin and liver enzymes [ Time Frame: 14 weeks ]
Information By: Children's Hospital Medical Center, Cincinnati
Dates:
Date Received: July 29, 2010
Date Started: July 2010
Date Completion: July 2025
Last Updated: April 26, 2017
Last Verified: April 2017