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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03510169
Eligibility Criteria:
Inclusion Criteria:
* 20 infants, admitted to Neonatal Intensive Care Unit (NICU) at St. Michael's Hospital
* \>1.5kg birthweight
* Clinically stable, with symptoms of respiratory distress (due to transient tachypnea of the newborn, respiratory distress syndrome, etc.)
* Stable on nasal CPAP (5-8cm H2O) for a minimum of 6 hours
* Within the first two weeks of life
Exclusion Criteria:
* Infants with FiO2 requirements \>0.35
* Infants with clinically significant apnoea or bradycardia (\> 2 A\&B in last hour, or apnea \>20 sec, or bradycardia requiring significant stimulation)
* Infants with hemodynamic instability (mean BP \< weeks GA), or any infant requiring fluid boluses and/or inotropic medications
* Infants with genetic conditions or dysmorphic facial features
* Infants that have been recently extubated in the last 48 hours
* Infants in whom placement of the NG tube is contra-indicated
* Infants with any clinical suspicion of upper airway distress such as symptoms of stridor
* Infants with abdominal wall defects and other visible abnormalities of the abdomen or chest
* Infants with umbilical arterial and/or venous catheters
* Infants that have allergies and/or previous skin reactions to silicone based materials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Hours
Maximum Age:
2 Weeks
Study:
NCT03510169
Study Brief:
Protocol Section:
NCT03510169