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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06697951
Eligibility Criteria:
Inclusion Criteria:
* Infants ≤ 28 days and \> 30weeks and/or \> 1000 gram (birthweight or admission weight if birthweight unknown)
* Mild to moderate respiratory distress (Downes' score 2 - 7)
* Parental/guardian permission (informed consent).
Exclusion Criteria:
* Congenital abnormality such that noninvasive positive pressure ventilation would be contraindicated (e.g. diaphragmatic hernia, cleft palate, tracheo-esophageal fistula)
* Need for immediate surgical intervention
* Suspected neuromuscular abnormality as evidenced by decreased tone
* Suspected cyanotic congenital cardiac disease or cardiac instability
* Severe life-threatening condition such that the doctor caring for the patient believes survival of patient will be less than 24 hours and/or parents request withdrawal of care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
28 Days
Study:
NCT06697951
Study Brief:
Protocol Section:
NCT06697951