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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT02412566
Eligibility Criteria:
Inclusion Criteria:
* Greater than 14 days old and less than 1 year of age.
* Greater than 1.5 kg.
* Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL, or currently receiving Omegaven (fish oil lipid emulsion) with a conjugated bilirubin between 0.0-1.9 mg/dL.
* Currently receiving 1 g/kg/day of either Omegaven (H-23365) or soy-based Intralipid (standard therapy)
* Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.
* Be expected to require intravenous nutrition for at least an additional 21 days.
Exclusion Criteria:
* Have a congenitally lethal condition (e.g. Trisomy 13).
* Have clinically severe bleeding or clinical liver failure 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
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
1 Year
Study:
NCT02412566
Study Brief:
Protocol Section:
NCT02412566