Status:
COMPLETED
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Lead Sponsor:
Kapiolani Medical Center For Women & Children
Conditions:
Cholestasis
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Detailed Description
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil tha...
Eligibility Criteria
Inclusion
- direct bilirubin \> 2 mg/dl x2 consecutive
- parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
- patient must have utilized standard therapies to prevent the progression of liver disease
Exclusion
- other primary cause of liver disease not parenteral nutrition-associated
- weight \<3 kg
- infant or child enrolled in other clinical trial involving an investigational agent
Key Trial Info
Start Date :
October 20 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01194063
Start Date
October 20 2010
End Date
January 15 2019
Last Update
February 15 2019
Active Locations (1)
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1
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826