CompletedPhase 1/2

Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

United States12 participantsStarted 2011-11

Plain-language summary

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Who can participate

Age range

1 Year

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: Cholestasis defined as either * serum bilirubin \> 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR * serum bilirubin \> 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis Exclusion Criteria: * Age \> 1y at time that omegaven is started * Not expected to survive at least 30 days * Fish allergy in a first degree relative * Hemodynamic instability * Coagulopathy * Not likely to require PN for \> 30d * Not expected to survive \> 30d

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

Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL)

Timeframe: approximately for 4 months

Trial details

NCT IDNCT01601652

SponsorArthur J De Lorimier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

Results submitted2020-11-17

View on ClinicalTrials.gov More Parenteral Nutrition Associated Cholestasis trials

Who can participate

Age range

1 Year

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.