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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT03690804
Eligibility Criteria:
Inclusion Criteria for the newborn :
* Neonates over 28 weeks of gestational age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France),
* performing a one hour (or more) kangaroo care session with his parent.
Inclusion Criteria for the parent (father or mother) :
\- To be a parent of a child eligible for the research protocol,
Exclusion Criteria for the newborn :
* Newborn sedated
* Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
* Associated and severe brain pathology
* Anoxo-ischemic encephalopathy
* Unbalanced congenital heart disease,
Exclusion Criteria for the parents :
* Parent with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
* Heart surgery or cardiac pathology
* History of psychiatric pathology
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Months
Study:
NCT03690804
Study Brief:
Protocol Section:
NCT03690804