Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant, Premature, Diseases
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 21
- Locations
- 3
- Primary Endpoint
- Ventilation/Perfusion Mismatch
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Ventilation/Perfusion Mismatch
Time Frame: variable; up to 2 hours
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
Secondary Outcomes
- Best CPAP Level(variable, up to 2 hours)