CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Bubble CPAP- BabiPlus, Respiralogics +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02392806
NCT02392806N/ACompleted

Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

Marya Strand, MD·interventional·Posted Mar 19, 2015·Updated Mar 9, 2018

In Brief

A clinical study evaluating Bubble CPAP- BabiPlus, Respiralogics and Bubble CPAP- B&B Bubbler, B&B Medical devices for Respiratory Distress Syndrome. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 19, 2015
Enrollment StartJan 1, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.3 years ago

Interventions

Bubble CPAP- BabiPlus, Respiralogicsdevice

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