Compassionate Use of Omegaven IV Fat Emulsion
Total Parenteral Nutrition-induced Cholestasis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Compassionate Use of Omegaven IV Fat Emulsion|
- Level of Bilirubin [ Time Frame: week 2, 3,4,and 8 ] [ Designated as safety issue: Yes ]measurement of bilirubin level weekly. Available data reported.
|Study Start Date:||December 2008|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
All subjects will receive Omegaven
Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.
Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.
It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816348
|United States, New York|
|Cohen Children's Medical Cenetr of New York at North Shore|
|Manhasset, New York, United States, 11030|
|Cohen Children's Medical Center of New York|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Cindy Haller, MD||Cohen Children's Medical Center of New York|