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 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT03969992
Eligibility Criteria:
Inclusion Criteria:
1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
2. 26 0/7 to 30 6/7 weeks of gestational age
3. Weight \<2.0 Kg
4. Respiratory Severity Score (RSS) 1.4-2.0
Exclusion Criteria:
1. Apgar score less than or equal to 5 at five minutes after birth
2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
3. Premature rupture of membranes (PROM) \> 14 days
4. Need for intubation and/or mechanical ventilation prior to enrollment
5. Active pneumothorax requiring chest tube
6. Significant congenital anomaly, chromosomal abnormality
7. Concomitant treatments with inhaled nitric oxide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
26 Weeks
Maximum Age:
31 Weeks
Study:
NCT03969992
Study Brief:
Protocol Section:
NCT03969992