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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Approved for marketing
CT.gov ID
NCT01425567
Collaborator
(none)
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous Lipid Emulsion Comprised of Fish Oil

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).

Study Design

Study Type:
Expanded Access
Official Title:
Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Days to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria :

    • 14 days <24 months* Anatomic short gut (< 50 % bowel removed) with total bilirubin > or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin > or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days * Patients with direct bilirubin > or = 6 mg/dL who do not meet criteria above but meet criteria with * If infants qualify for high risk ARM (gastroschisis, ileal atresia, <750 grams and stage III NEC) d bilirubin >1 mg/dL but less than 4 mg/dL.

    Exclusion Criteria:

    Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health System San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Cynthia Blanco, MD, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT01425567
    Other Study ID Numbers:
    • HSC2011-0211T
    First Posted:
    Aug 30, 2011
    Last Update Posted:
    Feb 12, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by The University of Texas Health Science Center at San Antonio
    cholestasis
    parenteral nutrition
    Additional relevant MeSH terms:
    Liver Diseases
    Fat Emulsions, Intravenous

    Study Results

    No Results Posted as of Feb 12, 2019