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 range

6 Months

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cholestasis trials