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 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT01721512
Eligibility Criteria:
Inclusion Criteria:
* Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
* Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.
Exclusion Criteria:
* 1\. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
* 2\. Multiple birth
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
6 Weeks
Study:
NCT01721512
Study Brief:
Protocol Section:
NCT01721512