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

Overview

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.

Full Title of Study: “Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children”

Study Type

  • Study Type: Expanded Access

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).

Interventions

  • Drug: Intravenous Lipid Emulsion Comprised of Fish Oil
    • IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Days

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center at San Antonio
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cynthia Blanco, MD, Principal Investigator, University of Texas

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