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:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06411405
Eligibility Criteria:
Inclusion criteria
* Neonates born at one of the study sites
* Neonates born at ≥34 weeks gestational age, defined by:
* Ultrasound scan, where participant has had an ultrasound scan during routine antenatal care
* If no ultrasound scan has been done, according to last menstrual period date, according to mother
* If no ultrasound scan has been done and the mother does not know her last menstrual period date, the neonate will be eligible for inclusion if their birth weight is ≥1400g which will include the majority of births ≥34 weeks according to the results of the INTERGROWTH-21st Project(44)
Exclusion criteria
* Neonates born at \<34 weeks gestational age, due to their higher background risk of sepsis, and automatic admission to the neonatal unit with antibiotic administration
* Neonates with congenital abnormalities or syndromes associated with increased susceptibility to infection will be excluded (e.g. gastroschisis).
* Neonates whose mothers are unable to provide informed consent
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT06411405
Study Brief:
Protocol Section:
NCT06411405