Trial Outcomes & Findings for Comparative Effectiveness Study of Bubble CPAP Devices in the NICU (NCT NCT02392806)

Results Overview

Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Within 72 hours of extubation

Results posted on

2018-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	22	21
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bubble CPAP- BabiPlus, Respiralogics n=22 Participants 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	Bubble CPAP - B&B Bubbler, B&B Medical Technologies n=21 Participants 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	Total n=43 Participants Total of all reporting groups
Age, Continuous	26.0 Weeks Gestational Age STANDARD_DEVIATION 2.0 • n=5 Participants	25.4 Weeks Gestational Age STANDARD_DEVIATION 1.4 • n=7 Participants	25.7 Weeks Gestational Age STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 72 hours of extubation

Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation

Outcome measures

Outcome measures
Measure	Bubble CPAP- BabiPlus, Respiralogics n=22 Participants 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	Bubble CPAP - B&B Bubbler, B&B Medical Technologies n=21 Participants 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
Number of Participants With Extubation Failure	9 Participants	7 Participants

SECONDARY outcome

Timeframe: 96 hours

Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours

Outcome measures

Outcome measures
Measure	Bubble CPAP- BabiPlus, Respiralogics n=22 Participants 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	Bubble CPAP - B&B Bubbler, B&B Medical Technologies n=21 Participants 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
Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly	5 Participants	5 Participants

Adverse Events

Bubble CPAP- BabiPlus, Respiralogics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bubble CPAP - B&B Bubbler, B&B Medical Technologies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Noah Hillman

Saint Louis University

Phone: 3145779292

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place