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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01370967
Eligibility Criteria:
Inclusion Criteria:
* Healthy, term (37-42 weeks gestation), singleton infant at birth.
* Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.
* At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.
Exclusion Criteria:
* Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment.
* Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Days
Maximum Age:
49 Days
Study:
NCT01370967
Study Brief:
Protocol Section:
NCT01370967