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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06053684
Status
Recruiting
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Conditions

  • Bronchiolitis

Eligibility Criteria

Sex
ALL
Age
0 Years - 2 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Non-Invasive Mechanical Servo Ventilation — DEVICE
    The active comparator arm will utilize a standard non-invasive mode to provide ventilation support
  • Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation — DEVICE
    The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support

Study Details

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.

Key Dates

Start date
Dec 18, 2023
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Non-Invasive Mechanical Servo Ventilation Arm
    This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.
  • Experimental: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm
    This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.

Primary Outcome Measure

Baseline Respiratory Severity Score (RSS) [ Time Frame: Approximately one hour after Edi catheter placement ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital at MontefioreThe BronxNew York10467
Timothy Brandt, MD
718-619-7494

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By research site
Children's Hospital at Montefiore· The Bronx, NY

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