Clinical Trial: Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Brief Summary: The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
Detailed Summary:
Sponsor: University of California, Davis
Current Primary Outcome: Normalization of conjugated bilirubin (conjugated bilirubin < 2 mg/dL) [ Time Frame: approximately for 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Liver transaminases [ Time Frame: approximately for 4 months ]
Original Secondary Outcome: Same as current
Information By: University of California, Davis
Dates:
Date Received: May 9, 2012
Date Started: November 2011
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016