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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06260566
Eligibility Criteria:
Inclusion Criteria:
* 122-273 days of life at time of enrollment
* Confirmed diagnosis of biliary atresia based on intraoperative cholangiogram
* Able to tolerate oral nutrition and medications and not on continuous tube feeds
* Anticipated inpatient admission of at least 4 days
* Legal guardian(s) consent to study enrollment after understanding the risks and investigational nature of the study
Exclusion Criteria:
* Gestational age of \<32 weeks at birth
* Inability or contraindication to taking oral nutrition
* Neonatal intensive care unit admission
* Short bowel, or other malabsorptive, syndrome
* Decompensated liver disease (INR \> 1.3 despite vitamin K administration)
* Active respiratory infection
* Severe concurrent illnesses that would interfere with the conduct and/or results of the study
* Concurrent participation in another drug trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
122 Days
Maximum Age:
273 Days
Study:
NCT06260566
Study Brief:
Protocol Section:
NCT06260566