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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01383850
Eligibility Criteria:
Inclusion Criteria:
* inborn infants between 28 and 32 weeks of GA
* Silverman score \> 5,
* radiological finding of RDS
* a requirement of inspiratory flow of oxygen (FiO2) \> 0,25 (SaO2 ) between 88-95% within the first hour of life.
Exclusion Criteria:
* major congenital malformations
* intraventricular hemorrhage (IVH) more than grade 2
* need of intubation in the delivery room or requirement of FiO2 \>0,4 during the first hour of life.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
32 Weeks
Study:
NCT01383850
Study Brief:
Protocol Section:
NCT01383850