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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT04264156
Eligibility Criteria:
Inclusion Criteria:
* Signed ICF from legally authorized representative.
* Gestational age: 26 to 32+6 weeks PMA.
* Successful implementation of non-invasive support or ventilation within 30 minutes after birth.
* Spontaneous breathing.
* Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis.
* Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 \> 0.25 to ≤ 0.35 to maintain SpO2 of 90% to 95%.
Exclusion Criteria:
* A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth.
* Recurrent episodes of apnea requiring positive pressure ventilation.
* A 5 minute Apgar score \< 5.
* Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP.
* Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function.
* A known or suspected chromosomal abnormality or syndrome.
* Premature rupture of membranes \> 3 weeks.
* Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.
* A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study.
* The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids.
* Presence of air leak on the baseline chest radiograph or diagnosed via ultrasound or illumination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Minutes
Maximum Age:
6 Hours
Study:
NCT04264156
Study Brief:
Protocol Section:
NCT04264156