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

Status unconfirmed · Phase 2

Conditions studied: Short Bowel Syndrome, Cholestasis

In brief

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.

Key facts

Study ID

NCT01739517

Run by

Amarnath, Rathna, M.D.

People needed

20

Starts

2009-03-01

Expected to finish

2013-12-01

Last updated by the study team

2012-12-03

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Palmetto Health Children's Hospital — Columbia, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.