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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07329192
Eligibility Criteria:
Inclusion Criteria:
* Term newborn ≥ 37 weeks of gestation
* Birth weight \> 3000 g
* Growth \> 5th percentile according to Fenton curves
* No diagnosed or suspected pathology during antenatal care or the maternity stay
* No postnatal complications requiring temporary hospitalization in the neonatal unit or kangaroo care unit
Exclusion Criteria:
* Pathology diagnosed or suspected in the newborn during the maternity hospital stay.
* Requirement for temporary hospitalization in a neonatal unit or kangaroo care unit, including but not limited to: neonatal jaundice, abnormal oxygenation or laboratory findings, suspected early-onset bacterial infection, transient respiratory distress requiring more than 2 hours of non-invasive ventilation at birth, monitoring of mother-infant bonding, or maternal treatments during pregnancy necessitating clinical monitoring.
* Language barrier in both parents.
* Parents (legal guardians) informed of the study and having declined participation for themselves and their child.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07329192
Study Brief:
Protocol Section:
NCT07329192