NCT02534077

Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

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

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Pediatrix · Academic / Other
• Sex: All
• Age: 14 Days – 2 Years
• Healthy volunteers: Not accepted

Summary

To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Detailed description

Compassionate Use

Conditions

• Total Parenteral Nutrition-induced Cholestasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omegaven	Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
DRUG	Omegaven	Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.
DRUG	Omegaven	If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.

Timeline

• First posted: 2015-08-27
• Last updated: 2024-07-26

Locations

1 site across 1 country: United States