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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT07183956
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants born at \>28 weeks of gestation or term infants born at ≥37 weeks of gestation.
* Development of respiratory distress within the first 6 hours after birth, defined as the presence of at least two of the following: Respiratory rate ≥60/min, Subcostal/intercostal retractions, Grunting.
* Persistence of respiratory distress for more than 6 hours.
* Age within the first 12 hours of life.
* Silverman-Andersen score ≥3.
* Receiving NIPPV support.
Exclusion Criteria:
* Major congenital malformations.
* Airway or pulmonary anomalies.
* Cardiovascular or respiratory instability due to sepsis.
* Cyanotic congenital heart disease.
* Severe intraventricular hemorrhage.
* Contraindications for NIPPV therapy (e.g., congenital nasal anomalies, congenital diaphragmatic hernia, abdominal wall defects).
* Requirement of intubation or chest compressions in the delivery room.
* Requirement of intubation within the first hour of life.
* Death within the first 24 hours of life.
* Gestational age ≤28 weeks.
* Diagnosis of air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Hours
Maximum Age:
12 Hours
Study:
NCT07183956
Study Brief:
Protocol Section:
NCT07183956