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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT06599593
Eligibility Criteria:
Children will be eligible for inclusion in the trial if they meet all of the following criteria:
* Live in the study community
* Eligible for SMC
* No allergy to peanuts or cow's milk
* Able to orally feed
* Within the eligible age ranges:
* 6-59 months for passive surveillance
* 6-24 months for SQ-LNS provision
* Written informed consent from at least one caregiver
* Caregiver is at least 18 years of age
Children will be recruited during normal distribution (via door-to-door delivery) for SMC, which occurs monthly during the malaria season (July through October).
Children ages 3-6 months are eligible for SMC and will be included in nutritional screening and monitoring by default but will not be eligible for SQ-LNS, which is designed for children ages 6-24 months and will not be part of the passive surveillance.
A random sample of children ages 6-24 months during the first month of distribution will be asked to participate in an active surveillance cohort. These children will be followed biweekly for screening for malaria with a rapid diagnostic test and temperature and monthly for dried blood spot and anthropometric measurements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT06599593
Study Brief:
Protocol Section:
NCT06599593