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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT02819050
Eligibility Criteria:
Inclusion Criteria:
* Born between 23 0/7 - 30 6/7 weeks GA
* At least 26 0/7 weeks corrected GA.
* On NCPAP for at least 24 hours
* Stable on ≤0.3 FiO2 for at least 24 hours
Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours:
* Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.3.
* All babies \< 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose).
* Stable respiratory system assessment (respiratory rate of \< 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation \> 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
* If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
* A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
* Meeting "stability criteria" defined below:
* The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
* Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
* The infant could have no significant chest recession (sternal/diaphragmatic)
Exclusion Criteria:
* Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
* Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
* Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
* Grade IV intraventricular hemorrhage
* Inability to obtain informed parental consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
26 Weeks
Study:
NCT02819050
Study Brief:
Protocol Section:
NCT02819050