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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT05734768
Eligibility Criteria:
Inclusion Criteria:
Children and their parents will be included in the study in the exposed group if:
* the infant is born preterm, i.e., between 32 weeks of amenorrhea (SA) and 36 SA + 6 days.
* at the maternity ward of the University Hospital of Reims
* the parents are older than 18 years.
* parents are affiliated to a social insurance.
* parents agreed to participate in the study, within 72 hours after birth
Will be included in the study, in the non-exposed group, children and their parents, if:
* the children is born at term, i.e., from 37 SA + 0 Days
* at the maternity ward of the Reims University Hospital
* parents are older than 18 years.
* parents are affiliated to a social insurance.
* parents agreed to participate in the study, within 72 hours after birth
Exclusion Criteria:
Will not be included in the study, children and their parents, if:
* the infant is born from multiple pregnancy
* the infant is hemodynamically unstable
* the birth occured more than 72 hours ago
* the infant is affected by congenital malformations
* the infant is affected by severe brain lesion detected by transfontanellar ultrasound scan performed before inclusion (cystic leukomalacia, and stages III and IV of the Papille classification i.e. severe ventricular dilatation or intra-parenchymal hemorrhage)
* separation from the parents and placement of the child is intended
* child is born anounymously
* parents with psychiatric disorders
* if the mother is suffering from hemodynamic compromise
* parents under guardianship
* parents non-native speaking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05734768
Study Brief:
Protocol Section:
NCT05734768