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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04017520
Eligibility Criteria:
Inclusion Criteria:
* Mothers between the ages of 18 years adn 35 years
* Mothers plan to breast feed for minimum of 16 weeks (cessation of breastfeeding prior to this timepoint will not result in exclusion)
* Infants delivered at term (37 - 42 weeks)
Exclusion Criteria:
* Maternal morbidities that could affect ability to breastfeed or influence the breast milk micro-transcriptome (eg. cancer, drug addiction, HIV).
* Plan for infant adoption, or family move \>150 km from the medical center within 12 months of delivery
* Presence of congenital anomaly or neonatal condition that significantly affects a newborn's ability to feed (e.g. cleft lip/palate, metabolic disease, or prolonged neonatal intensive care unit (NICU) admission \>7 days)
* Plan to seek primary pediatric care outside the academic medical center
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
7 Days
Study:
NCT04017520
Study Brief:
Protocol Section:
NCT04017520