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

NCT ID: NCT02929303


Title
Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease
Purpose
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.
Details
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
Keywords
Source
Advocate Health Care
Sponsors
Hector Hernandez
Status
Available
Acronym
Last Updated
06 Oct 2016
URL
Official Link
Citations/Publications
Sant'Anna AM, Altamimi E, Clause RF, Saab J, Mileski H, Cameron B, Fitzgerald P, Sant'Anna GM. Implementation of a multidisciplinary team approach and fish oil emulsion administration in the management of infants with short bowel syndrome and parenteral nutrition-associated liver disease. Can J Gastroenterol. 2012 May;26(5):277-80.

Soden JS, Lovell MA, Brown K, Partrick DA, Sokol RJ. Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. J Pediatr. 2010 Feb;156(2):327-31. doi: 10.1016/j.jpeds.2009.08.033.

Locations
United States