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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06833294
Eligibility Criteria:
Inclusion Criteria:
1. Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg.
2. Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours.
3. Children whose nares, face, or head fit at least one of the GentleFit NIV interfaces.
4. Parental/guardian permission (informed consent).
Exclusion Criteria:
1. Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs.
2. Facial anomalies (e.g. cleft lip).
3. Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin.
4. Patient's emergent condition.
\-
Sex:
ALL
Minimum Age:
38 Weeks
Maximum Age:
3 Years
Study:
NCT06833294
Study Brief:
Protocol Section:
NCT06833294