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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT06691932
Eligibility Criteria:
Inclusion Criteria:
* Lactating mothers between 20-40 years old at enrollment
o 120 mother/infant dyads who primarily feed HM ATB (average \>75% of feeds,
* pumping no more than one time per day)
o 120 mother/infant dyads who predominantly feed expressed HM (average \>75% of feeds)
* All races and ethnicities may enroll
* Singleton infant delivered after 37 weeks
* Infant between the ages of 0-1 months at the time of enrollment.
* No serious health complications in mother or infant
Exclusion Criteria:
* Non-English-speaking subjects as study personnel only speak English
* Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)
* Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
40 Years
Study:
NCT06691932
Study Brief:
Protocol Section:
NCT06691932