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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07350018
Eligibility Criteria:
Inclusion Criteria:
* Born at a participating study center hospital.
* Gestational age between 24 1/7 and 29 6/7 weeks (\<30 0/7 weeks).
* Postnatal age within the first 6 hours of life.
* Being on non-invasive respiratory support.
* Presence of clinical and radiological findings consistent with respiratory distress syndrome (RDS).
* Indication for surfactant therapy defined as a requirement for FiO₂ \>30% to achieve target oxygen saturation (SpO₂ 90-94%) while receiving noninvasive respiratory support with a minimum pressure of 6 cmH₂O.
* Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
* Infants who were intubated for any reason before the decision to administer surfactant.
* Severe birth asphyxia, defined as the need for advanced resuscitation after birth, 10th minute Apgar score ≤5, and arterial blood gas within the first hour of life showing pH \<7.0 and base excess (BE) ≤-12.
* Presence of major congenital anomalies.
* Respiratory distress due to causes other than respiratory distress syndrome (RDS).
* Congenital heart disease.
* Congenital diaphragmatic hernia.
* Pulmonary hypoplasia.
* Chromosomal abnormalities.
* Presence of pneumothorax.
* Lack of informed consent.
* Neonatal seizures presence.
* Postnatal age greater than 6 hours.
* Infants born outside of gestational weeks 24 1/7 - 29 6/7.
* Requirement for invasive mechanical ventilation at enrollment.
* Infants receiving noninvasive respiratory support with an FiO₂ requirement \<0.30.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
6 Hours
Study:
NCT07350018
Study Brief:
Protocol Section:
NCT07350018