Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

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.

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. -