N/A
Completed N=43
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Source: ClinicalTrials.gov NCT02392806 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With Extubation Failure — 9; 7 Participants — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Extubation Failure |
9; 7 | >0.05 |
| SECONDARY Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly |
5; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Infant delivered at >=500 grams and 1250 grams or <500 grams.
- Non-English speaking parents. -
Data sourced from ClinicalTrials.gov (NCT02392806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.