UnknownPhase 2/3

Minimization of IntraLipid Versus Omegaven

Canada40 participantsStarted 2010-12

Plain-language 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 minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Feasibility

Timeframe: up to 1 year

Clinical endpoint

Timeframe: up to 1 year

Trial details

NCT IDNCT01247012

SponsorChildren's & Women's Health Centre of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

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