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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT03505203
Eligibility Criteria:
Inclusion Criteria:
1. Infant \> 37 0/7 weeks gestational age, apparently healthy and without significant morbidity
2. Singleton infant
3. Nursery/NICU/maternity stay of 7 days or less
4. Mother at least 17 years of age
5. Mother self-identifies as African American
6. Mother is primiparous
Exclusion Criteria:
1. Non-English speaking
2. Infant birth weight \<2500 grams
3. Presence of a congenital anomaly or neonatal physical or metabolic condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
4. Any major maternal morbidities, pre-existing condition that would affect postpartum care or her ability to care for her newborn (e.g., narcotic drug use: heroin, cocaine, meth, pain pills, etc; on chemotherapy; uncontrolled MS; uncontrolled depression causing social service contact).
5. Plan for newborn to be adopted
6. Plan to move from area within four months of delivery
7. Residence further than 75 miles from Augusta, GA
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT03505203
Study Brief:
Protocol Section:
NCT03505203