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Non-Invasive Ventilation for Bronchiolitis in Children

This study is looking at two types of breathing support for babies and young children (up to 2 years old) with bronchiolitis, a common lung infection. Researchers want to see if Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation helps children breathe more comfortably and reduces the need for more intensive treatments, like intubation (a breathing tube). NAVA works by better matching the breathing machine to the child's own breathing efforts. The study compares NAVA to standard Non-Invasive Mechanical Servo Ventilation. To join, children must have bronchiolitis and their doctor must feel either treatment is equally suitable for them. Children with certain other health conditions, like chronic lung disease, cannot participate.

Study design
This study plans to enroll 130 children and compares two different types of non-invasive breathing support.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Respiratory Severity Score (RSS) will be measured for 48 hours, with readings taken about every 4 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06053684

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

Recruiting
NAAges 0–2InterventionalTreatment
Montefiore Medical Center
~130 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:Standard Non-Invasive Mechanical Servo VentilationNeurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline Respiratory Severity Score (RSS)
Measured over Approximately one hour after Edi catheter placement
+3 more outcomes measured

Conditions

Bronchiolitis

Explore related trials

Bronchiolitis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jacqueline Weingarten, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Jacqueline Weingarten, MD
[email protected]
2017459825
Email the study team

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Eligibility criteria

Inclusion

Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU
Patient's provider believes there is equipoise between the use of NAVA or conventional non-invasive ventilation for the patient

Exclusion

Patients unable to utilize a nasogastric tube
Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure
Patients with hypotonia
Patients likely to require imminent intubation: \>0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) \> 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality)
Patients with hemodynamic instability, defined as the need for vasoactive medication

What this trial measures

  • Baseline Respiratory Severity Score (RSS)Approximately one hour after Edi catheter placement

    RSS is a validated measure of severity in children with bronchiolitis, scored from 0-12 with higher numbers indicating greater severity. If able, baseline scores will be taken before randomization to either treatment arm.

  • Average Respiratory Severity Score (RSS)48 hour average, values collected at ~4 hour intervals.

    RSS is a validated measure of severity in children with bronchiolitis, scored from 0-12 with higher numbers indicating greater severity. Average RSS values over a 48-hour period will be reported for each treatment arm.

  • Baseline Electrical Activity of the Diaphragm (Edi)Approximately one hour after Edi catheter placement

    Measure, in microvolts, recorded by the Edi catheter to reflect activity of diaphragmatic activation. Higher values correspond with increased diaphragmatic activation. If able, will be collected prior to randomization to either treatment arm.

  • Average Baseline Electrical Activity of the Diaphragm (Edi)48 hour average, values collected at ~4 hour intervals.

    Measure, in microvolts, recorded by the Edi catheter to reflect activity of diaphragmatic activation. Higher values correspond with increased diaphragmatic activation. Average Edi values over a 48-hour period will be reported for each treatment arm.