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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01425567
Eligibility Criteria:
Inclusion Criteria :
\- \>14 days \<24 months\* Anatomic short gut (\< 50 % bowel removed) with total bilirubin \> or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin \> or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days \* Patients with direct bilirubin \> or = 6 mg/dL who do not meet criteria above but meet criteria with \* If infants qualify for high risk ARM (gastroschisis, ileal atresia, \<750 grams and stage III NEC) d bilirubin \>1 mg/dL but less than 4 mg/dL.
Exclusion Criteria:
Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
24 Months
Study:
NCT01425567
Study Brief:
Protocol Section:
NCT01425567