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:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT04030312
Eligibility Criteria:
Mother-infant pairs will be consented for participation via informed written consent.
Inclusion Criteria:
* Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
* Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
* Infant with blood glucose after delivery of \< 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
* Deliverying mother plans to exclusively breastfeed.
Exclusion Criteria:
* Infants born and directly admitted to the newborn intensive care unit
* Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
* Infants deemed ward of state
* Mothers who do not plan to exclusively breastfeed at time of delivery
* Mothers less than 19 years of age
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
72 Hours
Study:
NCT04030312
Study Brief:
Protocol Section:
NCT04030312