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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: Completed NA study, sponsored by University of Florida.
NCT03242057 is a NA study that has completed, run by University of Florida. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
assess how many infants stayed extubated at 5 days after 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 |
What the finished NCT03242057 record still lists
NCT03242057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which NAVA is the first listed.
NCT03242057 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03242057's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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