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Compassionate Use of Omegaven IV Fat Emulsion

NCT02477345 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2017-12-08

No results posted yet for this study

Summary

This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The protocol involves infants and children with parenteral nutrition-associated liver disease to enable the reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).

Conditions

Interventions

DRUG

Omegaven IV

Omegaven will be initiated at a dose of 0.5 gram/Kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/Kg/day. Omegaven will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven will continue until weaned from PN. Monotherapy with Omegaven can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/Kg/day, advancing to 1 gm/kg/day.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Jonathan Blau, MD · Staten Island University Hospital

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02477345 on ClinicalTrials.gov