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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT06275932
Eligibility Criteria:
Inclusion Criteria:
For mother
* Mothers' age over 18 years and good comprehension of Italian language;
* Signed informed consent of the mother.
For newborn
* Informed consent signed by both parents, or in the case of a single-parent family, by mother
* Gestational age at birth greater than or equal to 37+0 weeks
* Newborns from singleton pregnancies;
* Both male and female newborns;
* Newborns who will be born from vaginal birth.
Exclusion Criteria:
For mother
* Mothers who do not want to carry out skin-to-skin contact;
* Mothers who do not understand/speak the Italian language;
* Mothers who need assistance procedures that hinder skin-to-skin contact.
For newborn
* Newborns whose parents decline participation in the study;
* Newborns with major congenital anomalies (heart, brain, metabolic, gastrointestinal);
* Newborns born via cesarean section;
* Newborns whose parents are under 18 years old, in the case of a single parent the mother who is under 18 years;
* Newborns requiring neonatal resuscitation after birth with obstruction of the skin-to-skin contact.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06275932
Study Brief:
Protocol Section:
NCT06275932