Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced L… (NCT02534077) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
United States
Plain-language summary
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
Who can participate
Age range
14 Days – 2 Years
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
. Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.
. Be expected to require intravenous nutrition for at least an additional 28 days
. Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:
. Parental informed consent must be signed.
Exclusion criteria
. Have a congenitally lethal condition (e.g. Trisomy 13).
. Have clinically severe bleeding not able to be managed with routine measures.
. Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
. Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
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.