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NCT03242057 · ClinicalTrials.gov registry record · NA
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03242057 is a NA study that has completed, run by University of Florida. The registered enrollment target is 30 participants.
The verdict
NCT03242057, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are the most commonly used. A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared to nCPAP (30% vs. 40%) NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported to improve patient - ventilator synchrony and minimize mean airway pressure and ability to wean an infant from a ventilator. However till date there has been no head to head comparison of extubation failure in infants managed on NAVA with conventional ventilator strategies. In this study the investigators aim to compare primary extubation failure rates in infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA ventilator settings and will be assessed for primary extubation failure (defined as reintubation within 5 days after an elective extubation).
Interventions
- OTHER NAVA
- OTHER NIPPV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2019-09-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03242057
The ClinicalTrials.gov registry entry for NCT03242057 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NAVA is the first listed.
NCT03242057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03242057 about?
NCT03242057 is a clinical study titled "Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA". Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous positive airway press...
What is the current status of trial NCT03242057?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2017-10-23. Estimated completion is 2019-09-05.
What interventions are being tested in trial NCT03242057?
The interventions under investigation include: NAVA (OTHER), NIPPV (OTHER).
Who is sponsoring clinical trial NCT03242057?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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