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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03230032
Eligibility Criteria:
Inclusion Criteria:
* PMA at enrollment \>32 6/7 and \<42 AND
* Diagnoses of Grade III/IV IVH, hydrocephalus or PVL, neonatal encephalopathy or thrombosis/infarct with involvement of the posterior limb of the internal capsule OR
* Abnormal GMA by certified study staff and masked gold-standard reading
Exclusion Criteria: Infants cannot be
* on assisted ventilation
* receiving more than 50% of their feeds orally averaged over the 72 hours prior to study start
* receiving less than 50% of their feeds enterally
* receiving enteral feed for greater than 60 min.
* considered medically unsafe to feed orally by the medical or feeding team as defined by unit/clinical protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
32 Weeks
Maximum Age:
12 Months
Study:
NCT03230032
Study Brief:
Protocol Section:
NCT03230032