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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT01517958
Eligibility Criteria:
Inclusion Criteria:
* gestational age ≥ 28 weeks
* symptoms of respiratory distress defined as:
* tachypnea (respiratory rate \> 60 breaths per minute)
* FiO2 requirement \>21%
* intercostal/subcostal retractions
* grunting and/or nasal flaring
* If clinically warranted, a chest x-ray will be done as part of the workup for respiratory distress; these patients with CXR will be included in the study.
* Inclusion criteria for the control group will be gestational age ≥ 28 weeks with no symptoms of respiratory distress (defined above).
Exclusion Criteria:
* neonates with prenatally diagnosed structural cardiac disease
* major multiple congenital anomalies
* other causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Weeks
Study:
NCT01517958
Study Brief:
Protocol Section:
NCT01517958