Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

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.
    

Intervention name(s): Bubble CPAP- BabiPlus, Respiralogics; Bubble CPAP- B&B Bubbler, B&B Medical devices
Intervention type(s): Device; Device
Intervention description(s): Infant will be randomized to BabiPlus Bubbler at time of extubation; Infant will be randomized to B&B Bubbler at time of extubation
Other intervention name(s): Bubble Continuous Positive Airway Pressure (BCPAP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous positive airway pressure; CPAP; Bubble CPAP; Extubation failure; Preterm infant