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:
NCT07109856
Eligibility Criteria:
Inclusion Criteria:
* birth weight ≥ 2000 grams
* Signs of respiratory distress at time-point of inclusion (tachypnoea \>60/min, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory support)
* Decision to conduct full life support
* Written informed consent obtained within the first 6 hours after birth, before inclusion in the study
* Age \< 6 hours
Exclusion Criteria:
* No decision to conduct full life support
* No written informed consent
* Birth weight \< 2000 grams
* Age \> 6 hours
* Severe congenital malformations,
* Umbilical cord artery pH \<7.20
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
6 Hours
Study:
NCT07109856
Study Brief:
Protocol Section:
NCT07109856