Title
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Use of Omegaven for Parenteral Nutrition Associated Liver Disease
Phase
Phase 3Lead Sponsor
Kapiolani Medical Center For Women & ChildrenStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
CholestasisIntervention/Treatment
icosapent ethyl ...Study Participants
36Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.
daily intravenous administration of Omegaven fish oil emulsion
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Inclusion Criteria: direct bilirubin > 2 mg/dl x2 consecutive parenteral nutrition dependent, expected to continue for at least another 30 days from the first day patient must have utilized standard therapies to prevent the progression of liver disease Exclusion Criteria: other primary cause of liver disease not parenteral nutrition-associated weight <3 kg infant or child enrolled in other clinical trial involving an investigational agent
