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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT04632069
Eligibility Criteria:
Inclusion Criteria:
* Infants of diabetic mothers who are failing oral feeding, \>39weeks gestation at enrollment, who are clinically stable, on minimal respiratory support (nasal cannula or room air), and clinical team has determined are G-tube candidates
Exclusion Criteria:
* Unstable infants or those requiring positive pressure respiratory support
* Infants \<39 weeks gestation at enrollment
* Major unrepaired congenital anomalies or anomalies that limit feeding volumes
* Infants with cardiomyopathy
* Repeated episodes of autonomic instability (apnea/ bradycardia) not self resolving
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
5 Months
Study:
NCT04632069
Study Brief:
Protocol Section:
NCT04632069