Respiratory Distress SyndromeNCT02392806
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
A study testing Bubble CPAP- BabiPlus, Respiralogics and Bubble CPAP- B&B Bubbler, B&B Medical devices in people with Respiratory Distress Syndrome, run by Marya Strand, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 100 days
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Bubble CPAP- BabiPlus, Respiralogics and Bubble CPAP- B&B Bubbler, B&B Medical devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 100 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant delivered at >=500 grams and <=1250 grams birth weight.
- Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.
- Infant has received exogenous surfactant during mechanical ventilation.
Who cannot join
- Decision by attending physician to redirect to comfort care
- Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)
- Birth weight >1250 grams or <500 grams.
- Non-English speaking parents. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
About this study
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.
Read the 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
- Being tested
- Bubble CPAP- BabiPlus, Respiralogics, Bubble CPAP- B&B Bubbler, B&B Medical devices
- Keywords
- Continuous positive airway pressure, CPAP, Bubble CPAP, Extubation failure, Preterm infant
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble CPAP- BabiPlus, RespiralogicsDevice
Also called Bubble Continuous Positive Airway Pressure (BCPAP)
Infant will be randomized to BabiPlus Bubbler at time of extubation
Bubble CPAP- B&B Bubbler, B&B Medical devicesDevice
Infant will be randomized to B\&B Bubbler at time of extubation
| Study group | Role | What they receive |
|---|---|---|
| BabiPlus, Respiralogics | Active comparator | 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 for 24 hours Receives: Device: Bubble CPAP- BabiPlus, Respiralogics |
| B&B Bubbler, B&B medical Technologies | Active comparator | 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 for 24 hours Receives: Device: Bubble CPAP- B&B Bubbler, B&B Medical devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Extubation Failure
Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation
Measured: Within 72 hours of extubation
Secondary outcomes (1)
Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly
Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marya Strand, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marya Strand, MD, St. Louis University
- Investigators
- Noah H Hillman, M.D., Principal investigator, Associate Director, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392806
- Sponsor's protocol ID
- SLU Protocol # 24949
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2015
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
- ClinicalTrials.gov ID
- NCT02392806
- Acronym / sponsor ID
- SLU Protocol # 24949
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Continuous positive airway pressure, CPAP, Bubble CPAP, Extubation failure, Preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Marya Strand, MDUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 26 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BabiPlus, Respiralogics | Active comparator | Device: Bubble CPAP- BabiPlus, RespiralogicsInfants 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 for 24 hours |
| B&B Bubbler, B&B medical Technologies | Active comparator | Device: Bubble CPAP- B&B Bubbler, B&B Medical devicesInfants 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 for 24 hours |
Who may qualify
- Ages
- 1 day to 100 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant delivered at >=500 grams and <=1250 grams birth weight.
- Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.
- Infant has received exogenous surfactant during mechanical ventilation.
Key exclusion criteria (4 listed)
- Decision by attending physician to redirect to comfort care
- Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)
- Birth weight >1250 grams or <500 grams.
- Non-English speaking parents. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bubble CPAP- BabiPlus, RespiralogicsAlso: Bubble Continuous Positive Airway Pressure (BCPAP)Infant will be randomized to BabiPlus Bubbler at time of extubation | Device | BabiPlus, Respiralogics |
| Bubble CPAP- B&B Bubbler, B&B Medical devicesInfant will be randomized to B\&B Bubbler at time of extubation | Device | B&B Bubbler, B&B medical Technologies |
Primary outcome
Number of Participants With Extubation Failure
Time frame: Within 72 hours of extubation
Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation
1 secondary outcome
Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly
Time frame: 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah H Hillman, M.D. principal investigator
Associate Director, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubble CPAP- BabiPlus, Respiralogics and Bubble CPAP- B&B Bubbler, B&B Medical devices in people with Respiratory Distress Syndrome, run by Marya Strand, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Extubation Failure (time frame: Within 72 hours of extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.