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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT03045757
Eligibility Criteria:
Inclusion Criteria:
* Full-term newborns with normal physical exam that are delivered \> 37 weeks gestation (healthy newborn arm).
or
* Newborn with CHD born \> 37 weeks gestation, are hemodynamically stable and who require surgical correction in the first 30 days of life (CHD arm).
Exclusion Criteria:
* Full-term newborn arm
* Newborn admitted into the NICU
* Genetic syndromes
* Congenital abnormalities or signs of developmental delay
ยท Infants with CHD arm
* Newborn requiring intubation prior to evaluation (Note: Infants with CHD with genetic or other malformations not specifically mentioned will not be excluded due to their prevalence in this population)
* Down Syndrome
* Trisomy 13, Trisomy 18
* Congenital anomalies of facial structure or musculature specifically cleft lip, hard or soft palate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
3 Months
Study:
NCT03045757
Study Brief:
Protocol Section:
NCT03045757