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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT05030012
Eligibility Criteria:
Inclusion Criteria:
1. Infants delivered at a gestational age of less than or equal to 35 6/7 weeks (Preterm) being treated with high velocity nasal insufflation therapy for the management of respiratory distress syndrome
2. Patients that clinically require SpO2 maintenance within the target range of 90-95%
3. A need for supplemental oxygen as demonstrated by a required FiO2 \> 0.25 at enrollment
4. Requiring a flow rate of greater than 2 L•min-1 such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HVNI).
5. A minimum of 6 manual FiO2 adjustments in the 24hr period prior to trial enrollment.
6. Willing/Able to complete informed consent.
Exclusion Criteria:
1. Current patient weight of \<1000g or \>3500g at time of study
2. Major congenital abnormalities
3. Hemodynamic instability, defined as being outside of a normotensive range based on an infant's individual characteristics by clinician
4. Persistent unresolved apnea defined as: requiring 6 stimulations or more per 6 hours
5. Seizures
6. Ongoing sepsis
7. Meningitis
8. Clinician's concern regarding stability of the infant
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05030012
Study Brief:
Protocol Section:
NCT05030012