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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT01859533
Eligibility Criteria:
Inclusion Criteria:
* Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
* Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
* Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Exclusion Criteria:
* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
* Presence of any other cause of respiratory distress, eg.
* congenital malformations affecting the cardiorespiratory system ,
* chromosomal aberrations,
* depression at birth (Apgar score at 5 minutes of \< 7 or umbilical artery pH of \< 7.10),
* fetal hydrops,
* persistent pulmonary hypertension,
* and meconium aspiration syndrome.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Days
Study:
NCT01859533
Study Brief:
Protocol Section:
NCT01859533