NCT02392806

Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Marya Strand, MD · Academic / Other
• Sex: All
• Age: 1 Day – 100 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	Bubble CPAP- BabiPlus, Respiralogics	Infant will be randomized to BabiPlus Bubbler at time of extubation
DEVICE	Bubble CPAP- B&B Bubbler, B&B Medical devices	Infant will be randomized to B\&B Bubbler at time of extubation

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-03-19
• Last updated: 2018-03-09
• Results posted: 2017-12-26

Locations

1 site across 1 country: United States