Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

NCT ID: NCT02392806

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bubble CPAP- BabiPlus, Respiralogics

Intervention Type: DEVICE

Infant will be randomized to BabiPlus Bubbler at time of extubation

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Infant will be randomized to B\&B Bubbler at time of extubation

Interventions

Bubble CPAP- BabiPlus, Respiralogics

Infant will be randomized to BabiPlus Bubbler at time of extubation

Intervention Type: DEVICE

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

Infant will be randomized to B\&B Bubbler at time of extubation

Intervention Type: DEVICE

Other Intervention Names

Bubble Continuous Positive Airway Pressure (BCPAP)

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. -

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 100 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marya Strand, MD

OTHER

Sponsor Role: lead

Responsible Party

Marya Strand, MD

Associate Professor, Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Noah H Hillman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Director, Pediatrics

Locations

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Countries

United States

Other Identifiers

SLU Protocol # 24949

Identifier Type: -

Identifier Source: org_study_id