NCT01425567

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

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

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 14 Days – 24 Months
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Liver Disease

Interventions

Type	Name	Description
DRUG	Intravenous Lipid Emulsion Comprised of Fish Oil	IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease

Timeline

• First posted: 2011-08-30
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States