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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04450056
Eligibility Criteria:
Inclusion Criteria:
* Enrolled in the MaPPS Trial
* Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
* The infant must be term-born (\>37 weeks gestation)
* Infant must be 1 month + 14 days old at the time of recruitment
* Mothers must be willing to provide a complete breastmilk expression from one breast (either via breast pump or hand expression)
* Able to provide informed consent
Exclusion Criteria:
* Mother reports mixed feeding of her infant with nutritive feeds (i.e., any provision of formula or animal milk)
* The infant was born preterm (earlier than 37 weeks gestation)
* Mother does not wish to provide a complete breast expression of one breast
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
25 Years
Study:
NCT04450056
Study Brief:
Protocol Section:
NCT04450056