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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT03799861
Eligibility Criteria:
Inclusion Criteria: all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:
* intrauterine fetal demise
* birth weight
* congenital anomalies
* multiple gestation
* any maternal complication
Exclusion Criteria:
* Newborns transferred to the maternity unit following delivery at a referral hospital or in the community
* Miscarriages, or previable newborns, defined as gestational age \<28 weeks (or if gestational age is unavailable, birth weight \<1,000g) at the time of delivery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
45 Weeks
Study:
NCT03799861
Study Brief:
Protocol Section:
NCT03799861