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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT03780712
Eligibility Criteria:
Inclusion Criteria for the sepsis risk group (400 infants):
* Child born from mothers having one of the following criteria before delivery will be included in this study:
* Spontaneous preterm delivery (\<37 weeks of gestation time)
* Foul smelling / with meconium / colored / bloody amniotic liquid
* Rupture of membranes \> 18 hours
* Maternal fever at delivery
* Vaginal infection
* Child born at the maternity of CNHU (Centre National Hospitalier et Universitaire, Cotonou, Benin) or CHUMEL (Centre Hospitalier et Universitaire de la Mère et de l'Enfant Lagune, Cotonou, Benin) or HZAC (Hopital de zone d' Abomey-Calavi, Benin).
* Mother located near Abomey-Calavi. This criterion has been included to limit the follow-up expenses and spare the travel to the project staff in charge of the 3 month follow-up.
Inclusion Criteria for the control group (170 infants):
\- Child born from mothers enrolled in the RECIPAL study (Pregnancy-associated malaria and Intrauterine growth restriction in Benin)
Exclusion Criteria for both groups:
* HIV + status or unknown HIV status of the mother (as the mother and child will be part of the national program to take care of mother and child HIV+ at delivery)
* Parents do not consent to be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03780712
Study Brief:
Protocol Section:
NCT03780712