Compassionate Use of Omegaven in Children

Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants

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.

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.

Inclusion Criteria:

• Live in or temporarily relocate to Oklahoma
• Age less than 18 years, both sexes, all races
• Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
• Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
• Are not currently enrolled in another lipid emulsion study

Exclusion Criteria:

• Known food allergy to fish
• Known metabolic disorder of lipid metabolism
• Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
• Medical condition likely to result in death in the next 30 days