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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00578734
Eligibility Criteria:
Inclusion Criteria:
* ≥ 38 weeks (corrected age) to 2 years (24 months)
* Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours
* Persistent hypoxia
* Written informed consent
Exclusion Criteria:
* Mechanical Ventilation for \> 48 hours
* Oxygenation index ≥ 25, if arterial line was avialable
* Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange
* Neuromuscular disease or hypotonia
* Upper airway disease
* Baseline requirment for supplemental oxygen
* Untreated pneumothorax
* Off-label use of commercially available surfactant outside neonatal period
* History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody
* Head injury with Glasgow Coma Scale \< 8
* Brain death or impending brain death
* Do not resuscitate orders
* Cardiopulmonary resuscitation within 6 hours of meeting entry criteria
* Experimental therapy in which the intervention potentially affects respiratory outcomes
* Any transplant recipient
* Meconium aspiration syndrome
* Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Years
Study:
NCT00578734
Study Brief:
Protocol Section:
NCT00578734