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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT04685356
Eligibility Criteria:
Inclusion Criteria :
* Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.
* Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context
* Normal neurological examination between 36 and 41 weeks of corrected age
Exclusion Criteria:
* Intraventricular hemorrhage (III or IV), periventricular leukomalacia
* Brain MRI abnormalities performed after 36 weeks of corrected age
* Life-threatening pathology
* Severe congenital abnomality
* Severe maternal pathology (physical and / or mental)
* Parents whose native languageis not French
* Participation in another interventional study on the management of post-hospital neurodevelopment disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Weeks
Maximum Age:
32 Weeks
Study:
NCT04685356
Study Brief:
Protocol Section:
NCT04685356