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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05763693
Eligibility Criteria:
Inclusion Criteria:
* Aged 1-27 days old
* Birthweight \< 2500 g and/or weight-for-height Z score \<- 2 standard deviations at enrollment
* Weigh at least 1500 g at time of enrollment
* Able to feed orally
* Family intends to stay in the study area for at least 6 months
* Written informed consent from at least one caregiver
* Afebrile
* Caregiver at least 18 years old
* No known allergy to macrolides
* No hepatic failure manifested by neonatal jaundice
* Not currently an inpatient at the clinic
* Not being transferred to a hospital for clinical complications
Exclusion Criteria:
* Birthweight \> 2500 g
* Weigh less than 1500 g at time of enrollment
* Unable to feed orally
* Family planning to move within 6 months
* Mother/ caregiver not willing to participate
* Allergic to macrolides
* Hepatic failure manifested by neonatal jaundice
* Currently being seen as an inpatient at the clinic
* Currently being transferred to a hospital for clinical complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
27 Days
Study:
NCT05763693
Study Brief:
Protocol Section:
NCT05763693