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 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT03235661
Eligibility Criteria:
Inclusion Criteria:
* 1\. Gestational age (GA) is from 26 to 37 weeks;
* 2\. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
* 3\. Respiratory distress syndrome Silverman score \>5;
* 4\. Informed parental consent has been obtained.
Exclusion Criteria:
* 1\. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
* 2\. Major congenital malformations or complex congenital heart disease;
* 3\. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
* 4\. Cardiopulmonary arrest needing prolonged resuscitation;
* 5\. transferred out of the neonatal intensive care unit without treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Minutes
Maximum Age:
6 Hours
Study:
NCT03235661
Study Brief:
Protocol Section:
NCT03235661