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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT01093495
Eligibility Criteria:
Inclusion Criteria:
* Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation
* CPAP pressure of 5 cm H2O
* FiO2 requirement = or \<0.30
* Clinically stable on these CPAP parameters for 24 hours pre-randomization:
* Respiratory rate less than 60
* No significant chest recession
* No apnea requiring bagging and/or
* Not more than 6 apneas requiring stimulation in the preceding 24 h.
* Average saturation \> or = 87%
* Satisfactory ABG (pH\> 7.25, PCO2 \< 60, and Base deficit \< -8)
Exclusion Criteria:
* Life threatening congenital anomalies
* Congenital cyanotic heart diseases
* Congenital airway or chest wall abnormalities
* Pulmonary hypoplasia
* Known or suspected to have a neuromuscular disorder
* Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
36 Weeks
Study:
NCT01093495
Study Brief:
Protocol Section:
NCT01093495