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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT03499418
Eligibility Criteria:
Inclusion Criteria:
* A signed form of informed consent from parents (legal guardians).
* 32 0/7 to 41 6/7 weeks of gestation
* The need to support postnatal breathing, no later than 6 hours of life.
Exclusion Criteria:
* The need for intubation in the after-birth procedures
* Age above 6 hours of age from birth
* Congenital heart defects
* Congenital diaphragmatic hernia
* Other severe congenital malformations and genetically determined syndromes, diagnosed before and after birth, associated with higher risk of respiratory failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Minutes
Maximum Age:
6 Hours
Study:
NCT03499418
Study Brief:
Protocol Section:
NCT03499418