Back to resultsCompassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury (Omegaven)
Primary Purpose
Liver Disease
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Intravenous Lipid Emulsion Comprised of Fish Oil
Sponsored by
About this trial
This is an expanded access trial for Liver Disease focused on measuring cholestasis, parenteral nutrition
Eligibility 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 * 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
Sites / Locations
- University Health System
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01425567
First Posted
August 3, 2011
Last Updated
February 11, 2019
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT01425567
Brief Title
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
Acronym
Omegaven
Official Title
Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
cholestasis, parenteral nutrition
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Intravenous Lipid Emulsion Comprised of Fish Oil
Other Intervention Name(s)
Omegaven
Intervention Description
IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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 * 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Blanco, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28437326
Citation
Sorrell M, Moreira A, Green K, Jacob R, Tragus R, Keller L, Quinn A, McCurnin D, Gong A, El Sakka A, Mittal N, Blanco C. Favorable Outcomes of Preterm Infants With Parenteral Nutrition-associated Liver Disease Treated With Intravenous Fish Oil-based Lipid Emulsion. J Pediatr Gastroenterol Nutr. 2017 May;64(5):783-788. doi: 10.1097/MPG.0000000000001397.
Results Reference
derived
Learn more about this trial
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
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