NCT02929303

Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: —

Summary

This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.

Detailed description

The etiology of parenteral nutrition associated liver disease (PNALD) is currently considered multifactorial. Available treatment options for this disease process are limited and have achieved moderate success at best. Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. The investigators hypothesize that administering Omegaven™ to patients with PNALD in place of conventional fat emulsion may reverse cholestasis allowing patients to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

Conditions

• Total Parenteral Nutrition-induced Cholestasis

Interventions

Type	Name	Description
DRUG	Omegaven IV lipid emulsion	Therapy is started at a dose of 1 gm/kg/day over 12 hrs. Omegaven may be infused via a central or peripheral IV. If additional fat calories are needed they will be provided by the enteral route.

Timeline

• First posted: 2016-10-11
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States