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 @ 11:55 AM
Ignite Modification Date:
2025-12-24 @ 11:55 AM
NCT ID:
NCT03853161
Eligibility Criteria:
Inclusion Criteria:
* Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
* Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
* Signed parental informed consent by one of the parents
Exclusion Criteria:
* Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
* Presence of a pneumothorax prior to enrollment
* Hemodynamic instability due to sepsis or hemorrhage
* Inability to obtain parental consent
* Shortage of suitable equipment
* Infants who were intubated solely for surgery
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03853161
Study Brief:
Protocol Section:
NCT03853161