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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT05711966
Eligibility Criteria:
Inclusion Criteria:
Infants satisfying the following inclusion criteria will be eligible to participate:
1. Born at 24+0-27+6 in a tertiary neonatal intensive care unit participating in the trial (and)
2. Breathing independently and sufficiently with only nasal CPAP or NIPPV for respiratory support (and)
3. Written parental consent has been obtained (and)
4. Failing nasal CPAP or NIPPV during the first 24 hours of life
Exclusion Criteria:
1. Severe birth asphyxia or a 5-minute Apgar score less than 3
2. Prior endotracheal intubation for resuscitation or insufficient respiratory drive
3. Prolonged (\>21 days) premature rupture of membranes
4. Presence of major congenital abnormalities
5. Hydrops fetalis
6. Inherited disorders of metabolism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
27 Weeks
Study:
NCT05711966
Study Brief:
Protocol Section:
NCT05711966