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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT07123961
Eligibility Criteria:
Inclusion:
1. age \> 2 weeks (\> 38 weeks corrected gestational age) and \< 18 years (not yet had 18th birthday)
2. acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
3. ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset
4. hypoxemia defined as PaO2/FIO2 (measurement of the amount of oxygen dissolved in the blood plasma/concentration of inhaled oxygen) \> 300 (or SpO2/FIO2 (measurement of the percentage of hemoglobin in your blood that is carrying oxygen/concentration of inhaled oxygen) \> 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O (rate of pressure delivery) on two consecutive measurements 4 hours apart and sustained at the time of consent and randomization
5. bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI
Exclusion:
1. hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload
2. non-palliated or unrepaired cyanotic congenital heart disease
3. ventilated via tracheostomy at baseline prior to acute illness
4. obstructive airway disease determined to be the primary cause of respiratory failure
5. severe moribund state not expected to survive \> 72 hours
6. any limitations of care at time of screening
7. escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening
8. previous enrollment in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
38 Weeks
Maximum Age:
17 Years
Study:
NCT07123961
Study Brief:
Protocol Section:
NCT07123961