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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT05730569
Eligibility Criteria:
INCLUSION CRITERIA
* Fundal height between 24 and 27 cm
* Woman living in the health zone of Accart-Ville, Colma 1 or Farakan
* Woman not planning to give birth or move outside the study area in the first 6 months of the infant's life
* Gestational age between 24 weeks 0 completed day and 29 weeks 6 days (ultrasound)
* Monofetal pregnancy without visible malformation
* Woman agreeing to give her informed consent to participate in the study
* Delivery of a live birth
* Vaginal birth
* Absence of severe infectious pathology, severe pneumopathy or respiratory distress in the neonate
* Neonates who did not receive corticosteroids or antibiotics at birth
For Small Vulnerable Newborns (SVNs):
* Low birth weight: \<2500g; and/or,
* Preterm: born between the 34th and 37th week of pregnancy; and/or,
* Small for Gestational Age: \<10 percentile of INTERGROWTH-21st birthweight standards.
For healthy community controls:
* Neonate born after the 37th week of pregnancy; and,
* Birth weight \>2500g; and,
* ≥10 percentile of INTERGROWTH-21st birthweight standards; and,
* Possible match with a SVN neonate already recruited into the study.
EXCLUSION CRITERIA
* Fundal height \<24 cm or \>27 cm
* Woman living outside the sanitary zone of the Accart-Ville, Colma 1 or Farakan
* Woman planning to give birth outside the study area or to move from it within the first 6 months of the infants's life
* Gestational age \<24 weeks or ≥30 weeks (ultrasound)
* Multi-fetal pregnancy
* Malformation visible on ultrasound
* Cesarean delivery
* Neonate with severe infectious disease, severe pneumopathy or respiratory distress
* Neonate who received corticosteroids or antibiotics just after birth
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT05730569
Study Brief:
Protocol Section:
NCT05730569