Status:
UNKNOWN
Minimization of IntraLipid Versus Omegaven
Lead Sponsor:
Children's & Women's Health Centre of British Columbia
Collaborating Sponsors:
Child and Family Research Institute
Conditions:
Cholestasis
Parenteral Nutrition Associated Liver Disease (PNALD)
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE2
PHASE3
Brief Summary
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid m...
Detailed Description
Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises \>100...
Eligibility Criteria
Inclusion
- infants admitted to neonatal intensive care unit
- severe cholestasis, defined as conjugated bilirubin greater than 35
- receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
- signed consent
Exclusion
- hepatitis (TORCH or other viral infection)
- primary liver disease as etiology of cholestasis
- clinically severe bleeding not able to be managed with routine measures
- lethal congenital abnormalities
- congenital heart disease associated with right heart dysfunction
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01247012
Start Date
December 1 2010
End Date
December 1 2012
Last Update
September 7 2011
Active Locations (1)
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1
Children's & Women's Health Centre of BC
Vancouver, British Columbia, Canada