Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.
The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury|
- Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]Normalization or trend toward normalization of direct bilirubin level
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Single Omegaven® Intervention Arm
10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Other Name: IV Fish Oil Based Lipid Emulsion
|Contact: Ricardo A. Caicedo, MDemail@example.com|
|Contact: Michelle K. Chiu, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Levine Children's Hospital at Carolinas HealthCare System||Recruiting|
|Charlotte, North Carolina, United States, 28232-2861|
|Contact: Ricardo A. Caicedo, MD 704-381-8880 email@example.com|
|Principal Investigator:||Ricardo A. Caicedo, MD||Levine Children's Hospital at Carolinas HealthCare System|