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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT04432935
Eligibility Criteria:
Inclusion Criteria:
* Pregnant females aged 18 to 45 years with no underlying complications or co-morbidities
* Residence less than 30 kms away from the study clinic and have resided there for at least 1 year. Family MUST indicate that they will not move from their current residence for the 5 months after birth of the child (study period)
* Healthy singleton full-term births born to these mothers, regardless of birth weight and an APGAR score of 7 or higher 5 minutes after delivery with no underlying complication (randomization will take place at this stage)
Exclusion Criteria:
* Females with health issues and high risk pregnancies
* Neonates presenting with any morbidities and congenital anomalies will be excluded from the study
* Preterm birth (\<37 weeks of gestation)
* Immunodeficiency disorder in immediate family member
* Parents refusing to consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
23 Hours
Study:
NCT04432935
Study Brief:
Protocol Section:
NCT04432935