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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT07271368
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants ≥ 32 weeks of gestational age
* FiO₂ \> 0.30 for more than 30 minutes on CPAP (6 - 8 cm H₂O) or HFNC (8 l/min)
* Increased work of breathing despite FiO₂ \< 0.30
* Birth weight \> 800 g
* X-ray confirmed RDS
* Availability of all required devices and appropriately fitting cuirass
Exclusion Criteria:
* Requirement for endotracheal intubation or mechanical ventilation prior to surfactant administration
* Major congenital anomalies (cardiac, pulmonary, chromosomal)
* Known or suspected neuromuscular or metabolic disorders
* Lack or withdrawal of informed parental consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
3 Days
Study:
NCT07271368
Study Brief:
Protocol Section:
NCT07271368