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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05404594
Eligibility Criteria:
Inclusion Criteria:
* Experimental group: VPIs of gestational age less than or equal to 33 weeks on the day of birth and hospitalized in the neonatal intermediate care unit or the neonatal intensive care unit of the Neonatal department of the Hautepierre Hospital (Strasbourg University Hospital)
* Control group: Healthy full-term babies (\> 37 weeks gestational age) hospitalized in the maternity ward of Strasbourg University Hospital
* Consent obtained from both parents
* Subject affiliated to a social health insurance plan.
Exclusion Criteria:
* \- Any malformation known before inclusion
* Cerebral lesions discovered on cerebral ultrasound performed as part of the standard management of newborns (Intra-Ventricular Hemorrhages of grade III or IV of the Papile classification, Periventricular Leucomalacia)
* Unstable clinical status according to the investigator's judgment
* Expected transfer of the child to another hospital before the term of 40 weeks PMAs.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05404594
Study Brief:
Protocol Section:
NCT05404594