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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02764918
Eligibility Criteria:
Inclusion Criteria:
* Mother willing to sign informed consent form.
* Healthy infant
* No obvious congenital abnormalities or birth defects.
* Stable household with no plans to leave the area for the next one year.
Exclusion Criteria:
* Parents are not willing to have child's blood drawn.
* Parents are planning to enroll child into another interventional clinical study during the time period of this trial that could affect the outcomes of this study.
* Mother not willing to have blood drawn and breast milk extracted.
* Parents not willing to have field research assistant in home two times per week.
* History of seizures or other apparent neurologic disorders.
* Infant has any sibling currently or previously enrolled in this study, including a twin.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
7 Days
Study:
NCT02764918
Study Brief:
Protocol Section:
NCT02764918