MedTrace Logo

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

NCT02929303 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Total Parenteral Nutrition-induced Cholestasis

Interventions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Hector Hernandez, MD · Wake Forest University Health Sciences

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02929303 on ClinicalTrials.gov