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Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

NCT02392806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-03-09

Study results available
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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.

Conditions

  • Respiratory Distress Syndrome

Interventions

DEVICE

Bubble CPAP- BabiPlus, Respiralogics

Infant will be randomized to BabiPlus Bubbler at time of extubation

DEVICE

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

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

Sponsors & Collaborators

  • Marya Strand, MD

    lead OTHER

Principal Investigators

  • Noah H Hillman, M.D. · Associate Director, Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
100 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392806 on ClinicalTrials.gov