Compassionate Use of Omegaven in Children

NCT ID: NCT02370251


Title
Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Purpose
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
Details
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day. Up to 200 children will be eligible for enrollment. Direct bilirubin levels and other labs will be monitored as well as growth parameters.
Conditions
Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition
Keywords
Fat Emulsions, Intravenous, Parenteral-Nutrition-Associated Liver Disease, Cholestasis, Omegaven, Fish Oil
Source
University of Oklahoma
Sponsors
University of Oklahoma, OU Medical Center
Status
Recruiting
Acronym
Last Updated
17 Nov 2016
URL
Official Link
Locations
United States