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

Status:Approved for marketing
Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Age Range:Any

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Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

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.

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).

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
We found this trial at
San Antonio, Texas 78229
Principal Investigator: Cynthia Blanco, MD
Phone: 210-358-1593
San Antonio, TX
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