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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03710551
Eligibility Criteria:
Inclusion Criteria:
* Written Informed Consent
* Infants whose parents/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
* Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 28 days post-natal age at enrollment visit
* Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment
Exclusion Criteria:
* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Days
Maximum Age:
28 Days
Study:
NCT03710551
Study Brief:
Protocol Section:
NCT03710551