Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

February 9, 2018 updated by: Marya Strand, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 for 24 hours
Device: Bubble CPAP- BabiPlus, Respiralogics
Infant will be randomized to BabiPlus Bubbler at time of extubation
Other Names:
  • Bubble Continuous Positive Airway Pressure (BCPAP)
Active Comparator: 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 for 24 hours
Device: Bubble CPAP- B&B Bubbler, B&B Medical devices
Infant will be randomized to B&B Bubbler at time of extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 72 hours of extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly
Time Frame: 96 hours
Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marya Strand, MD

Investigators

  • Principal Investigator: Noah H Hillman, M.D., Associate Director, Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLU Protocol # 24949

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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