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

NCT02534077 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-07-26

No results posted yet for this study

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.

Conditions

  • Total Parenteral Nutrition-induced Cholestasis

Interventions

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.

Sponsors & Collaborators

  • Pediatrix

    lead OTHER

Principal Investigators

  • Kaashif Ahmad, MD · Pediatrix

Eligibility

Min Age
14 Days
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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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 NCT02534077 on ClinicalTrials.gov