Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn
Conditions
Keywords
CPAP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
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.
Interventions
DEVICEContinuous positive airway pressure (CPAP); level changes
as per arm description
Sponsors
Thrasher Research Fund
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Hours to 35 Weeks
Healthy volunteers
No
Inclusion criteria
1. Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission. 2. Age limits: 24 hours of age - 35 weeks corrected gestational age. 3. On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet. 4. 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
1. Congenital anomalies, as determined by the clinical supervising physician. 2. Current or prior air leak syndrome, as determined by the clinical supervising physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation/Perfusion Mismatch | 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
| Measure | Time frame | Description |
|---|---|---|
| Best CPAP Level | variable, up to 2 hours | Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Positive Airway Pressure (CPAP) Level Changes 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
Continuous positive airway pressure (CPAP); level changes: as per arm description | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Continuous Positive Airway Pressure (CPAP) Level Changes |
|---|---|
| Age, Continuous | 19 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
Time frame: variable; up to 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) Level Changes | Ventilation/Perfusion Mismatch | 1.2 difference in right shift (kPa) |
Comparison: Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs best CPAPp-value: 0.02Sign test
Secondary
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
Time frame: variable, up to 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) Level Changes | Best CPAP Level | 7 cm H2O |