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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT02277795
Eligibility Criteria:
Inclusion Criteria:
* Live-born male infants within the study catchment area (two facilities and their surrounding communities, respectively, served by Domiciliary Midwives (DMs))
* Ability to follow up three or four days after the procedure (and for the first 50 infants, ability to follow-up 24 hours, 3 days, 1 week, and 4 weeks after the procedure)
* Provision of written informed consent by at least one parent or guardian
Exclusion Criteria:
* Neonatal sepsis or signs of potential illness (e.g., hyperthermia or hypothermia)
* Penile abnormality that might require reconstructive surgery in the future
* Family history of bleeding disorder
* Estimated infant gestational age \< 37 weeks
* Infant delivery weight \< 2,500 grams
* Growth less than 5th percentile for age
* Infant \> 60 days of age
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
1 Day
Maximum Age:
60 Days
Study:
NCT02277795
Study Brief:
Protocol Section:
NCT02277795