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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT03058666
Eligibility Criteria:
Inclusion Criteria:
RDS Patients
1. NICU patient, ≥1hour of age and \<24 hours of age.
2. Clinical diagnosis of RDS, with or without chest X-ray data.
3. Inspired oxygen ≥21% to maintain adequate oxygen saturation.
4. Not intubated
5. Requiring:
1. nasal continuous positive airway pressure (nCPAP).
Exclusion Criteria:
1. Congenital anomaly limiting care options or requiring early surgery.
2. Cardiopulmonary decompensation.
1. hypotension with metabolic acidosis (base excess \< -10 meq/l).
2. Oxygen saturations \< 88% at start of aerosolization.
3. PaCO2 ≥ 60 mmHg at start of aerosolization.
3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
4. Acute hypoxic encephalopathy with or without seizures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
24 Hours
Study:
NCT03058666
Study Brief:
Protocol Section:
NCT03058666