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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00599651
Eligibility Criteria:
Inclusion Criteria:
* Birthweight \> 1200 grams
* Chronologic age \< 72 hours.
* Diagnosis of RDS by clinical and radiographic criteria.
* Treated with nasal CPAP and supplemental oxygen \> 30% and not requiring \> 60% FiO2 for longer than 30 minutes to maintain SaO2 88-95%.
* Parental consent.
Exclusion Criteria:
* Birthweight \< 1200 gms.
* Diagnosis other than RDS (e.g., meconium aspiration syndrome).
* Babies who require or have already had endotracheal intubation.
* Babies with congenital anomalies or conditions thought by the attending physician to contribute to respiratory symptoms and/or to restrict adequate spontaneous breathing (e.g., congenital heart disease, obtundation from maternal drugs, certain airway malformations, diaphragmatic hernia).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
72 Hours
Study:
NCT00599651
Study Brief:
Protocol Section:
NCT00599651