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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT04086095
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants with respiratory distress syndrome and the need for Surfactant administration (oxygen requirement with FiO2 ≥ 30% and/or mod. Silverman Andersen Respiratory Severity Score (RSS) ≥ 5)
* Respiratory support with non-invasive CPAP at the time of Surfactant administration
Exclusion Criteria:
* Preterms with an gestational age \< 26+0 weeks
* Preterms with malformations of the respiratory tract
* Clinical decision on intubation / surfactant application via endotracheal tube e.g. because of respiratory drive disorder
* (Missing parental consent)
* (Attending physician is not delegated by the principal investigator)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Days
Study:
NCT04086095
Study Brief:
Protocol Section:
NCT04086095