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Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

Cholestasis Clinical Trial

Official title:
Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01173159
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Completed
Phase N/A
Start date July 2010
Completion date December 2018
View Details
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