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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT02212002
Eligibility Criteria:
Inclusion Criteria:
* Term newborns (gestational age ≥ 37 weeks), vaginally delivered newborn
* birth weight adequate for gestational age
* mothers screened for GBS at 35-37 weeks gestation
* Obtained written parental consent.
Exclusion Criteria:
* Preterm or small/large for gestational age infants;
* Infants born by caesarean section;
* Infants admitted to the Neonatal Intensive Care Unit;
* Infants with major congenital malformations;
* Infants who received any antibiotic treatment after birth;
* Signs of infection and/or any serious clinical conditions that contraindicate the participation in the study;
* Infants whose mother had received any antibiotic in the 4 weeks before delivery;
* maternal IAP performed for reasons other than GBS positivity (i.e. prolonged rupture of membranes in GBS-negative women);
* inadequate maternal IAP;
* maternal IAP performed with antibiotics other than ampicillin, such as erythromycin
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Days
Study:
NCT02212002
Study Brief:
Protocol Section:
NCT02212002