Clinical trial NCT02392806: Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Official title: Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Continuous positive airway pressure
CPAP
Bubble CPAP
Extubation failure
Preterm infant
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Number of Participants With Extubation Failure
timeFrame: Within 72 hours of extubation
Secondary outcomes:
measure: Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly
timeFrame: 96 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
Study officials:
affiliation: Associate Director, Pediatrics
name: Noah H Hillman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: