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Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children (NCT02778698)

This expanded access protocol is for children that cannot get enough nutrients from food and must receive nutrition through a vein. The standard nutrition given through a vein is blend that has soybean fat. If this is given over a long period of time, it can cause problems. It can lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.
  • : Omegaven
    Ages eligible for Study
    up to 5 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Male or female
    • Older than 14 days and less than 5 years of age
    • Direct bilirubin value is greater than 2 mg/dL
    • Be expected to require intravenous nutrition for at least an additional 28 days
    • Parent/legal guardian has agreed to provide consent/parental permission
    Exclusion Criteria:
    • Patients who have a congenitally lethal condition (e.g. Trisomy 13).
    • Patients who have clinically severe bleeding not able to be managed with routine measures.
    • Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
    • Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
    • The parent/legal guardian is unwilling to provide consent/parental permission.
    Status:
    available
    Type:
    Expanded Access
    Phase:
    -
    Start:
    01 January, 0001
    Updated:
    31 July, 2017
    Participants:
    0
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