Respiratory Distress Syndrome
Conditions
Keywords
Continuous positive airway pressure, CPAP, Bubble CPAP, Extubation failure, Preterm infant
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBubble CPAP- BabiPlus, Respiralogics
Infant will be randomized to BabiPlus Bubbler at time of extubation
DEVICEBubble CPAP- B&B Bubbler, B&B Medical devices
Infant will be randomized to B&B Bubbler at time of extubation
Sponsors
Marya Strand, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 100 Days
Healthy volunteers
No
Inclusion criteria
1. Infant delivered at \>=500 grams and \<=1250 grams birth weight. 2. Infant requires intubation for mechanical ventilation within the first 48 hours following delivery. 3. Infant has received exogenous surfactant during mechanical ventilation.
Exclusion criteria
1. Decision by attending physician to redirect to comfort care 2. Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.) 3. Birth weight \>1250 grams or \<500 grams. 4. Non-English speaking parents. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Extubation Failure | Within 72 hours of extubation | Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly | 96 hours | Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Bubble CPAP- BabiPlus, Respiralogics | Bubble CPAP - B&B Bubbler, B&B Medical Technologies | Total |
|---|---|---|---|
| Age, Continuous | 26.0 Weeks Gestational Age STANDARD_DEVIATION 2 | 25.4 Weeks Gestational Age STANDARD_DEVIATION 1.4 | 25.7 Weeks Gestational Age STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
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
Time frame: Within 72 hours of extubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bubble CPAP- BabiPlus, Respiralogics | Number of Participants With Extubation Failure | 9 Participants |
| Bubble CPAP - B&B Bubbler, B&B Medical Technologies | Number of Participants With Extubation Failure | 7 Participants |
p-value: >0.05t-test, 2 sided
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
Time frame: 96 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bubble CPAP- BabiPlus, Respiralogics | Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly | 5 Participants |
| Bubble CPAP - B&B Bubbler, B&B Medical Technologies | Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly | 5 Participants |