Trial | NCT01739517  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    20
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.
Study Started
Mar 31
2009
Primary Completion
Dec 31
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Dec 03
2012
Estimate

Drug Omegaven Therapy

After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Omegaven Therapy Experimental

After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

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
No Results Posted