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| ID | Type | Description | Link |
|---|---|---|---|
| 825874 | Other Identifier | University of Pennsylvania |
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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous positive airway pressure (CPAP) level changes | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure (CPAP); level changes | Device | as per arm description |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Bamat, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| The Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36104165 | Derived | Bamat NA, Orians CM, Abbasi S, Morley CJ, Ross Russell R, Panitch HB, Handley SC, Foglia EE, Posencheg MA, Kirpalani H. Use of ventilation/perfusion mismatch to guide individualised CPAP level selection in preterm infants: a feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):188-193. doi: 10.1136/archdischild-2022-324474. Epub 2022 Sep 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | difference in right shift (kPa) | variable; up to 2 hours |
|
48 hours after intervention
Adverse event monitoring limited to air leak syndromes (pneumothorax, pulmonary interstitial emphysema, pneumomediastinum; as determined by the clinical supervising physician during routine clinical care) and respiratory deterioration, defined as an increase in baseline FiO2 greater than 0.10 in the 48 hour following the study intervention,
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Bamat, MD MSCE | University of Pennsylvania | 2155904010 | bamatn@email.chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 | Jul 24, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D001997 | Bronchopulmonary Dysplasia |
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Pennsylvania Hosptital | Philadelphia | Pennsylvania | 19107 | United States |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | cm H2O | variable, up to 2 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D012140 | Respiratory Tract Diseases |
| D012138 |
| Respiratory Therapy |