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Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis

StatusSuspended
PhaseNot applicable
Started
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Record History

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  1. Recruitment suspended Sponsor's reason: Study suspended pending outcome of discussions among IRB, PI, and DSMC Show 5 more changesShow less
    • Primary and study completion moved earlier from Mar 2027 to Dec 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
    • Publications: details revised at 12 of 13 entries
  2. Primary and study completion dates: Jul 2025 to Mar 2027
    • Enrollment target: 120 to 130
    • Eligibility criteria expanded, about 18 words
    v5
  3. Eligibility criteria expanded, about 6 words
    • Study description expanded, about 11 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2023 to Dec 18, 2023
    v3
  5. Start date: Oct 2023 to Nov 2023v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.
Trial Details
NCT Number NCT06053684
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Bronchiolitis
Related terms Bronchiolitis
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov