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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT04041505
Eligibility Criteria:
Inclusion criteria: Mother-infant dyads are eligible to participate if:
* mother is aged 19 years or older,
* dyads currently live in the Halifax Regional Municipality in Nova Scotia,
* mother has no chronic diseases,
* the baby is a healthy singleton baby who is younger than 6 weeks of age, and is fed mother's milk directly from the breast and from a bottle,
* mother plans to exclusively feed their baby mother's own milk up to 6 months,
* mother has/had an older child whom they successfully fed mother's own milk for a minimum of 6 months,
* mother is willing to participate in three 3-day study sessions and monthly measurement sessions, and
* mother provides informed consent for herself and her infant to participate.
Exclusion criteria: Mother-infant dyads are ineligible to participate if:
* the baby was born preterm (earlier than 37 weeks gestation),
* the baby was born outside the healthy weight range of 2,500 - 4,000 g (5lb 8oz to 8lb 13oz),
* the baby has a developmental delay diagnosed before the time of enrolment,
* the baby is currently receiving any medical treatment except for vitamin D supplementation (no more than 400 IU/day),
* the mother sought prescription medical treatment for lactation (e.g. domperidone, antibiotics, prescription nipple ointment), or
* the mother plans to move in the 6 months after starting the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04041505
Study Brief:
Protocol Section:
NCT04041505