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Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury — Omegaven  

Liver Disease Clinical Trial

Official title:
Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Clinical Trial Summary

To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

Clinical Trial Description

Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01425567
Study type Expanded Access
Source The University of Texas Health Science Center at San Antonio
Contact
Status Approved for marketing
Phase
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