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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT03997266
Eligibility Criteria:
I. Inclusion criteria: We will enroll newborn infants with gestational age of 23-30 weeks 6 days infants at participating study sites will be eligible.
II. Exclusion criteria:
1. Infants born for maternal indications via caesarean section with rupture of membranes at delivery, without attempts to induce labor, and without concern for maternal infection
2. Infants at high risk of EOS
* Infants born to mothers with intrapartum fever (\> 38C) or clinical diagnosis of chorioamnionitis
* Infants born to mothers with previous infant with GBS disease/infection
3. Infants with respiratory insufficiency requiring invasive mechanical ventilation and FiO2 \> 0.40 or non-invasive ventilation and FiO2 \> 0.60 at time of randomization
4. Infants with ongoing hemodynamic instability requiring vasopressors or fluid boluses at time of randomization
5. Clinician concern infant is at high risk for sepsis due to infant physical exam findings or clinical history of mother or infant
6. Major congenital anomalies
7. Infants not anticipated to survive beyond 72 hours
8. Infants who have received antibiotics prior to randomization
9. Mothers that are \<18 years old at time of enrollment
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Hours
Study:
NCT03997266
Study Brief:
Protocol Section:
NCT03997266