Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

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.

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 status