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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amarnath, Rathna, M.D.

Criteria

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