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The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP and room air | Active Comparator | Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. |
|
| Room air | No Intervention | Premature stable infants on CPAP and room air will be randomized to transition to room air alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP and room air | Device | Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants | Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation <10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society. | Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age). |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Passive Respiratory Compliance in Randomized Premature Infants | Measurements of passive respiratory compliance will be done with the single breath occlusion technique. | Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age |
| Passive Respiratory Resistance in Randomized Premature Infants |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Growth Parameters Between the Randomized Premature Infants | Changes in growth parameters will be compared between randomized groups. | From randomization through discharge at about 35-37 weeks of corrected gestational age. |
| The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy T McEvoy, MD, MCR | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31519441 | Derived | Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP and Room Air | Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone. |
| FG001 | Room Air | Premature stable infants on CPAP and room air will be randomized to transition to room air alone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: CPAP and Room Air | CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants | Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation <10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society. | Posted | Mean | Standard Deviation | mL | Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age). |
|
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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 | CPAP and Room Air | Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy McEvoy, MD | OHSU | 503-494-0223 | mcevoyc@ohsu.edu |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
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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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|
Measurements of passive respiratory resistance will be done with the single breath occlusion technique. |
| Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age. |
| Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants. | Characteristics of tidal flow volume loops will be measured. | Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age. |
Adverse events and serious adverse events occurring in the randomized groups will be documented carefully |
| From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age). |
| Corrected Gestational Age at Which Full Nipple Feeds Are Achieved | The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups. | Randomization through discharge at about 35-37 weeks of corrected gestational age. |
| Incidence of Wheezing Through One Year of Age | Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups. | Discharge through one year of corrected age |
| Cost Comparison Between Randomized Groups | Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups. | Through 12 months of corrected age |
| Days on Oxygen Between the Randomized Groups | The days of oxygen supplementation will be compared between the groups of randomized patients. | Through discharge at about 35-37 weeks of corrected gestational age |
| Days in the Hospital | The days in the hospital will be compared between the randomized groups. | Delivery through discharge at about 35-37 weeks of corrected gestational age |
| No Intervention: Room Air |
Premature stable infants on CPAP and room air will be randomized to transition to room air alone. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| CPAP and Room Air |
Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone. |
| OG001 | Room Air | Premature stable infants on CPAP and room air will be randomized to transition to room air alone. |
|
|
|
| Secondary | Measurements of Passive Respiratory Compliance in Randomized Premature Infants | Measurements of passive respiratory compliance will be done with the single breath occlusion technique. | Posted | Mean | Standard Deviation | mL/Kg | Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age |
|
|
|
|
| Secondary | Passive Respiratory Resistance in Randomized Premature Infants | Measurements of passive respiratory resistance will be done with the single breath occlusion technique. | Posted | Mean | Standard Deviation | cmH2O/mL/sec | Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age. |
|
|
|
| Secondary | Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants. | Characteristics of tidal flow volume loops will be measured. | Posted | Mean | Standard Deviation | mL | Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age. |
|
|
|
| Other Pre-specified | Changes in the Growth Parameters Between the Randomized Premature Infants | Changes in growth parameters will be compared between randomized groups. | Posted | Mean | Standard Deviation | g | From randomization through discharge at about 35-37 weeks of corrected gestational age. |
|
|
|
| Other Pre-specified | The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants. | Adverse events and serious adverse events occurring in the randomized groups will be documented carefully | Posted | Number | participants | From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age). |
|
|
|
| Other Pre-specified | Corrected Gestational Age at Which Full Nipple Feeds Are Achieved | The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups. | Posted | Median | Inter-Quartile Range | weeks | Randomization through discharge at about 35-37 weeks of corrected gestational age. |
|
|
|
| Other Pre-specified | Incidence of Wheezing Through One Year of Age | Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups. | Number of participants analyzed is lower here as we were not able to follow all infants through 1 year of corrected age. | Posted | Count of Participants | Participants | Discharge through one year of corrected age |
|
|
|
| Other Pre-specified | Cost Comparison Between Randomized Groups | Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups. | Data not collected | Posted | Through 12 months of corrected age |
|
|
| Other Pre-specified | Days on Oxygen Between the Randomized Groups | The days of oxygen supplementation will be compared between the groups of randomized patients. | Posted | Mean | Inter-Quartile Range | days | Through discharge at about 35-37 weeks of corrected gestational age |
|
|
|
| Other Pre-specified | Days in the Hospital | The days in the hospital will be compared between the randomized groups. | Data not collected | Posted | Delivery through discharge at about 35-37 weeks of corrected gestational age |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Room Air | Premature stable infants on CPAP and room air will be randomized to transition to room air alone. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012138 |
| Respiratory Therapy |
| At Discharge |
|
| Superiority |
| At Discharge |
|
| At Discharge |
|