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Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb. This study will determine if one Bubble CPAP device (BabiPlus vs B&B) is more effective in improving oxygenation and decreasing extubation failure in the extremely low birthweight population.
Primary outcome: Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation Secondary outcome: Number of infants that reach 21% inspired oxygen during initial study period Secondary outcome: Apnea/bradycardia events in the initial study period Secondary outcome: Mean oxygen requirement following initial study period
Population: Infants born at <=1250 grams birth weight but >= 500 grams birth weight
Randomization: Equal allocation stratified by gestational age (<27 weeks, >=27 weeks)
Study diagram:
72h 24h X---------->X1----------->Y2 Y---------->Y1----------->X2 Infants will be randomly assigned to treatment X (BabiPlus, control group) or treatment Y (B&B Bubbler, intervention group). The primary outcome is bubble CPAP failure during the first 72 hours following extubation, measured at time point 1 in the diagram. Bubble CPAP failure is defined as requiring re-intubation or non-invasive positive pressure ventilation (NIPPV), requiring FiO2 of >60% for one hour or a pCO2 measurement of >65 mm Hg. For those infants that remain on CPAP during the initial study period, the number that reach 21% inspired oxygen for >12 consecutive hours will be compared between groups. This difference will also be analyzed using a Chi square test.
Those infants that remain on CPAP following the 72 hour initial study period (e.g., did not meet primary outcome criteria) will be crossed over to the opposite treatment arm for at least 24 hours. The minimum oxygen requirement required to keep the saturations in the ordered range, per standard NICU guidelines, will be recorded and compared between time points 1 and 2.
This study design is complex due to the nature of the disease of these patients. Each day every infant's premature pulmonary disease is evolving. There is no way to control for this.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BabiPlus, Respiralogics | Active Comparator | Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device for 24 hours |
|
| B&B Bubbler, B&B medical Technologies | Active Comparator | Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device for 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bubble CPAP- BabiPlus, Respiralogics | Device | Infant will be randomized to BabiPlus Bubbler at time of extubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Extubation Failure | Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation | Within 72 hours of extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly | Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours | 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah H Hillman, M.D. | Associate Director, Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bubble CPAP- BabiPlus, Respiralogics | Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation |
| FG001 | Bubble CPAP - B&B Bubbler, B&B Medical Technologies | Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bubble CPAP- BabiPlus, Respiralogics | Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Extubation Failure | Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation | Posted | Count of Participants | Participants | Within 72 hours of extubation |
|
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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 | Bubble CPAP- BabiPlus, Respiralogics | Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B&B Bubbler device Bubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noah Hillman | Saint Louis University | 3145779292 | noah.hillman@health.slu.edu |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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| Bubble CPAP- B&B Bubbler, B&B Medical devices | Device | Infant will be randomized to B&B Bubbler at time of extubation |
|
| BG001 |
| Bubble CPAP - B&B Bubbler, B&B Medical Technologies |
Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation |
| BG002 | Total | Total of all reporting groups |
| Weeks Gestational Age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly | Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours | Posted | Count of Participants | Participants | 96 hours |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Bubble CPAP - B&B Bubbler, B&B Medical Technologies | Infants randomized to the B&B Bubbler device will be extubated to B&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device Bubble CPAP- B&B Bubbler, B&B Medical devices: Infant will be randomized to BabiPlus verses B&B Bubbler at time of extubation | 0 | 21 | 0 | 21 |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |