Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT02370251
Eligibility Criteria:
Inclusion Criteria:
* Live in or temporarily relocate to Oklahoma
* Age less than 18 years, both sexes, all races
* Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
* Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
* Are not currently enrolled in another lipid emulsion study
Exclusion Criteria:
* Known food allergy to fish
* Known metabolic disorder of lipid metabolism
* Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
* Medical condition likely to result in death in the next 30 days
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT02370251
Study Brief:
Protocol Section:
NCT02370251