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:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT07060833
Eligibility Criteria:
Inclusion Criteria:
* Infants on bCPAP with gestational age \< 32+0 weeks
* Postmenstrual age between 28+0 and 36+6 weeks at the time of the study
* Postnatal age greater than 168 hours (7 days) at the time of the study
* On the bubble CPAP device with binasal prongs at the time of the study
* Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L/min and 10L/min at the time of the study
Exclusion Criteria:
* Infants with known major congenital anomalies
* Infants with known congenital heart disorders
* Infants with known neuromuscular disease
* Infants receiving ventilator-derived CPAP at the time of the study
* Infants receiving CPAP via a nasal mask interface at the time of the study
* Infants receiving inotropes, narcotics or sedative agents at the time of the study
* Infants deemed clinically unstable for the study by the attending neonatologist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
32 Weeks
Study:
NCT07060833
Study Brief:
Protocol Section:
NCT07060833