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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02528851
Eligibility Criteria:
Inclusion Criteria:
* All preterm infants less than 37 weeks of gestation who are mechanically ventilated with Endotracheal Airway Pressure (EAP) ≥ 8 cm H2O at time of extubation as per the medical team.
Note: The decision to extubate a subject, and EAP at time of extubation, will solely be that of the medical team, and is in no way dictated by the study protocol.
Exclusion Criteria:
* Infants on EMV with EAP\> 11 cmH2O at the time of extubation
* Congenital or acquired abnormality of upper airway
* Major gastrointestinal disorder or complication
* Suspected/proven chromosomal/genetic abnormality
* Suspected/confirmed sepsis being treated at time of extubation
* Unresolved hemodynamically significant patent ductus arteriosus (with or without inotropic support) at time of extubation
* Congenital structural heart diseases
* Infants requiring vasopressor and/or inotropic support at time of extubation
* Persistent pulmonary hypertension requiring treatment with vasopressors/inhaled nitric oxide/sildenafil at time of extubation
* Any unplanned extubation in infants otherwise meeting the inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT02528851
Study Brief:
Protocol Section:
NCT02528851