Impact of CPAP Level on V/Q Mismatch in Premature Infants

Study Overview
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Brief Summary
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Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.

Official Title
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Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial

Conditions
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Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP); level changes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission. Age limits: 24 hours of age - 35 weeks corrected gestational age. On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) 0.25 for at least 2 consecutive hours, as documented on the bedside infant flow sheet. Exclusion Criteria: Congenital anomalies, as determined by the clinical supervising physician. Current or prior air leak syndrome, as determined by the clinical supervising physician.

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous positive airway pressure (CPAP) level changes<br>Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline | Device: Continuous positive airway pressure (CPAP); level changes<br>* as per arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation/Perfusion Mismatch | Measured by non-invasive computerized technique based on curvilinear characteristics generated by a best-fit curve connecting the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs; measured as difference in degree of right-shift between baseline and best CPAP | variable; up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best CPAP Level | Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level | variable, up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchopulmonary Dysplasia, CPAP, Ventilator Induced Lung Injury, V/Q mismatch