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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03744169
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 37 weeks gestational age and less than 18 years
* Admitted to PICU
* Clinical diagnosis of acute respiratory failure
* Requirement of non-invasive or invasive respiratory support (as defined by a clinical need for high flow nasal cannula \>1L/kg/min; RAM cannula, nasal or full face mask delivered continuous positive airway pressure ventilation; RAM cannula, nasal or full face mask delivered bi-level positive airway pressure ventilation; or invasive mechanical ventilation); requirement of supplemental oxygen with FiO2 \> 0.35 while on high flow nasal cannula \<1L/kg/min to maintain saturations \> 90%; continuous nebulized therapy; or chronic use of home oxygen or ventilator support AND any increase in home settings
Exclusion Criteria:
* Hemodynamically unstable as defined by the initiation of or the need for increased vasopressor support within the previous 30 minutes
* Known chronic respiratory disease such as primary ciliary dyskinesia, cystic fibrosis, or congenital pulmonary malformations.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03744169
Study Brief:
Protocol Section:
NCT03744169