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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01526018
Eligibility Criteria:
Inclusion Criteria:
* healthy, exclusively formula-fed infants aged 1-6 months at enrollment;
* parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.
Exclusion Criteria:
* born \< 37 weeks;
* birth weight \< 2500g or \> 4000g;
* current weight \< 10th percentile for age;
* hospitalization \> 72 hours following birth or any hospital admission since birth;
* any health issue that could interfere with feeding and/or growth;
* use of complementary foods;
* inability or unwillingness to comply with study-related procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
6 Months
Study:
NCT01526018
Study Brief:
Protocol Section:
NCT01526018