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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT02092857
Eligibility Criteria:
Inclusion criteria:
* healthy term infants
* birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
* receiving \>80% for their intake by mouth from commercial infant formula
* low-risk for allergy based on a negative family history.
Exclusion criteria:
* corticosteroid use
* red cell or plasma transfusions
* IV lipid emulsions prior to study entry
* major congenital malformations
* systemic or congenital infection
* significant neonatal morbidity
* maternal autoimmune disorders
* acute illness precluding oral feedings or conditions requiring feedings other than standard formula
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
21 Days
Study:
NCT02092857
Study Brief:
Protocol Section:
NCT02092857