Compassionate Use of Omegaven in Children
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies, Gastrointestinal, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Reproductive |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/3/2019 |
| Start Date: | June 2015 |
| End Date: | September 26, 2019 |
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.
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.
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
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