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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT05821569
Eligibility Criteria:
Inclusion Criteria:
1. Full term healthy newborn
2. Weight \> 2500 gr
3. Vaginal delivery
4. Breastfeeding already started
5. Absence of breast problems (e.g. cracked or sore nipple)
6. Parents' consent to research participation
Exclusion Criteria:
1. Syndromic diagnosis (genetic/hereditary)
2. Condition affecting a major organ (heart disease, cerebropathy, etc.)
3. Medication intake that may interfere with the data collection (e.g. analgesics)
4. Newborn head lesion that may interfere with the fNIRS assessment (e.g. due to an operative delivery)
5. Mother history of neurological or neurosensory disorder, psychosis, bipolar disorder, and substance abuse or addiction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
7 Days
Study:
NCT05821569
Study Brief:
Protocol Section:
NCT05821569