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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT01287559
Eligibility Criteria:
Inclusion Criteria:
* Neonates weighing 500-1,500 g on admission
* Neonates eligible for full care and resuscitation as necessary (no parental request for D.N.R.)
* Enrollment within 12h of suspected NEC; scanning within 24h of diagnosis (unless matched control)
* Informed consent
Exclusion Criteria:
* Refusal or withdrawal of consent
* Skin or mucosal integrity disorders, beyond prematurity (e.g. epidermolysis bullosa, herpes simplex)
* Major congenital malformations and gastrointestinal tract malformation precluding initiations of feeds(e.g., congenital obstruction of GI tract, gastroschisis, omphalocele)
* critically ill neonates, who are unlikely to survive
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Weeks
Study:
NCT01287559
Study Brief:
Protocol Section:
NCT01287559