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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04526860
Eligibility Criteria:
Mother infant dyads are eligible for the study, with equal proportion of male and female infant in each study group.
Inclusion Criteria:
* Breast Milk Calibration Study: Study women (pre-pregnant BMI\>30) who are providing exclusive human milk via pumping and bottle (50%/50% male/female) will be recruited at the 7-9 week postpartum visit.
* Formula Milk Calibration Study: Study women (pre-pregnant BMI\>30) who are providing formula via bottle (50%/50% male/female) will be recruited at the 7-9 week postpartum visit.
Exclusion Criteria:
* Breast Milk Calibration Study: breast implants, prior breast surgery, flat/ inverted nipples, tongue-tie or low birth weight infants.
* Formula Milk Calibration Study: low birth weight infants.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04526860
Study Brief:
Protocol Section:
NCT04526860