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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07442669
Eligibility Criteria:
Inclusion Criteria:
* Inborn at 27 0/7 to 34 6/7 weeks of gestational age
* Spontaneously breathing at birth but requiring non-invasive respiratory support
* RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS
Exclusion Criteria:
* Outborn
* Endotracheal intubation in the delivery room or within 2 hours of life
* Surfactant in the delivery room as part of advanced resuscitation
* Presence of major congenital malformations or chromosomal anomalies
* Hydrops fetalis
* Inherited disorders of metabolism
* Air leak syndrome (pneumothorax, pneumomediastinum) prior to surfactant administration, congenital diaphragmatic hernia, congenital pneumonia, meconium aspiration syndrome
* Infants in extremis not expected to survive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
27 Weeks
Maximum Age:
34 Weeks
Study:
NCT07442669
Study Brief:
Protocol Section:
NCT07442669