Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 1 |
| Updated: | 4/2/2016 |
| Start Date: | March 2009 |
| End Date: | December 2013 |
This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high
in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition
dependent patients with short gut syndrome.
in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition
dependent patients with short gut syndrome.
Inclusion Criteria:
- Patient will be dependent upon parenteral nutrition (PN)
- Patient will have short gut syndrome (loss of >50% of small bowel)
- Patient's guardian/caregiver provides informed consent for patient to receive therapy
- Pediatric patient ≤ 1 year of age
- Expected PN duration is greater than 30 days
- Direct bilirubin >2.0 mg/dL measured on two occasions no more than one week apart
Exclusion Criteria:
- Liver dysfunction secondary to cause other than PN verified by standard of care
diagnostic procedures and lab work to rule out alternative causes of neonatal
cholestasis.
- Any patient in whom Omegaven therapy would be contraindicated, such as an allergy to
any seafood product, egg protein, and/or previously established allergy to Omegaven
- impaired lipid metabolism
- severe hemorrhagic disorder
- unstable diabetes mellitus
- collapse and shock, stroke/embolism, recent cardiac infarction, or undefined coma
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