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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT03353051
Eligibility Criteria:
Inclusion Criteria:
Low Birth Weight (LBW) neonates:
* Medical stable neonates
* Neonatal weight ≥2000g and \<2500g
* Born at Serrekunda Hospital
* Gestational age will be \>37 weeks.
* Born to mothers at least 18 years of age
Preterm neonates with Low Birth Weight (PTB+LBW):
* Medical stable neonates
* Born at Serrekunda Hospital
* Neonates weighing \<2500g and \<37 weeks of gestational age.
* Born to mothers at least 18 years of age
Preterm (PTB) neonates:
* Medical stable neonates
* \>32 and \<37 weeks' gestational age
* Born at Serrekunda Hospital
* PTB neonates will weigh more than 2500g
* Born to mothers at least 18 years of age
Full Term (FT) neonates:
* Healthy neonates
* Born at Serrekunda Hospital
* FT neonates will weigh ≥2500g
* Gestational age ≥37 weeks
* Born to mothers at least 18 years of age
Exclusion Criteria:
* Major congenital malformations
* Severe birth asphyxia
* Children from multiple births
* Medication (i.e. prophylactic antibiotics) given to neonate before first neonatal venous blood draw
* Neonates born via Breech, Vacuum or C section
* Neonates with infection/illness (information gained from venous bleed) will no longer be required to give future samples if originally required
Sex:
ALL
Minimum Age:
5 Minutes
Maximum Age:
28 Days
Study:
NCT03353051
Study Brief:
Protocol Section:
NCT03353051