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

This study is currently recruiting participants.
Verified June 2012 by The University of Texas Health Science Center at San Antonio
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01425567
First received: August 3, 2011
Last updated: February 14, 2013
Last verified: June 2012
History of Changes
  Purpose

If a child is unable to tolerate enough of his/her feeding orally to grow and requires that nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease. This is called cholestasis. IV fat that children receive may be contributing to this liver disease. A different fat mixture comprised from fish oil could be used in place of intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We believe the use of fish oil may provide less liver disease and decrease the need of liver transplant or dying than those who receive the usual fat.


Condition Intervention
Liver Disease
 Drug: Intravenous Lipid Emulsion Comprised of Fish Oil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • death associated to liver disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Death only associated to liver disease


Secondary Outcome Measures:
  • Liver transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Liver transplant secondary to parenteral nutrition associated liver disease


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven Intravenously Drug: Intravenous Lipid Emulsion Comprised of Fish Oil
IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease
Other Name: Omegaven

Detailed Description:

If a child is unable to tolerate enough of his/her feeding orally to grow and requires that nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease. This is called cholestasis. IV fat that children receive may be contributing to this liver disease. A different fat mixture comprised from fish oil could be used in place of intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We believe the use of fish oil may improve liver disease and decrease the need of liver transplant or dying than those who receive the usual fat. The rest of the IV nutrition is as per standard of care

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 *

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425567

Locations
United States, Texas
University Health System Recruiting
San Antonio, Texas, United States, 78229
Contact: Laurie Weaver, RN     210-358-1593     laurie.weaver@uhs-sa.com    
Principal Investigator: Cynthia Blanco, MD            
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Cynthia Blanco, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01425567     History of Changes
Other Study ID Numbers: HSC2011-0211T
Study First Received: August 3, 2011
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
cholestasis
parenteral nutrition

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013