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:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT03078218
Eligibility Criteria:
Inclusion Criteria:
BEFORE Period: newborns
* aged at birth superior or equal to 35 weeks of gestation (≥ 35+ 0 days weeks of gestation)
* borned in metropolitan France in involved maternity wards.
* Asymptomatic before the screening (no respiratory signs, neither collapse or cardiac arrest).
AFTER Period: newborns
* aged at birth superior or equal to 35 weeks of gestation (≥ 35+ 0 days weeks of gestation)
* borned in metropolitan France in involved maternity wards.
* Asymptomatic before the screening (no respiratory signs, neither collapse or cardiac arrest).
* With consent done by the 2 parents.
* Parents covered with the French National health insurance
Exclusion Criteria:
* Newborns with a prenatally diagnosed congenital cyanotic malformation or any other cyanotic affection.
* Newborns with a postnatal pre-screening diagnosed congenital cyanotic malformation or any other cyanotic affection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
24 Hours
Study:
NCT03078218
Study Brief:
Protocol Section:
NCT03078218