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

August 28, 2025 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bronchiolitis is a common diagnosis in pediatric hospitals and critical care units. Viral infection in younger patients often results in increased work of breathing, hypoxemia, impaired ventilation, and increased secretion burden. In some cases, treatment of severe respiratory failure includes intubation and mechanical ventilation. Current practice for patients with bronchiolitis who require hospital admission is to initially provide non-invasive ventilation to improve the patient's respiratory mechanics. This non-invasive respiratory support can range from simple nasal cannula, to high-flow nasal cannula, to non-invasive positive pressure ventilation.

The high-flow nasal cannula (HFNC) provides warm, humidified, oxygen-enriched air. Therapy commonly is prescribed with a prescribed fraction of inhaled oxygen (FiO2) delivered at 1-2 L/kg/min. This helps to improve oxygenation as the high rate of flow can "wash-out" carbon dioxide in the upper airways and thus reduce the volume of dead space ventilation.

Non-invasive ventilation (NIV) essentially provides a similar method of support as invasive ventilation without the use of endotracheal tube. Prescribed airway support is instead delivered non-invasively through a specialized nasal cannula or for larger children an occlusive facemask of appropriate size. The ventilator provides positive-end expiratory pressure (PEEP) with a prescribed delivery rate of a set inspiratory pressure (positive inspiratory pressure, or pressure control). This ventilator support enables the delivery of a set FiO2, helps maintain open airways to reduce atelectasis and allow for improved oxygenation with better V/Q matching, and improves work of breathing. The ventilator analyzes the flow generated by the patient's inspiratory effort and attempts to provide the prescribed positive inspiratory pressure at the time of the patient's own effort.

One of the major drawbacks of non-invasive ventilation for young pediatric patients with bronchiolitis is the difficulty in achieving synchrony between patient effort and ventilator-delivered positive inspiratory pressure. This is secondary to the large air leak given the non-invasive apparatus and the low inspiratory flows generated by this patient population. Thus, the ventilator and patient are often dyssynchronous which may actually increase work of breathing and agitation while impeding on the ventilatory support provided.

Neurally-Adjusted Ventilatory Assistance (NAVA) attempts to mitigate the harms of ventilator/patient dyssynchrony. This modality utilizes a specialized catheter placed into the esophagus, often via a nasogastric route, which has the capability of monitoring the electrical activity of the patient's diaphragm. This catheter can also be utilized to deliver feeds similarly to a basic nasogastric tube. The NAVA catheter monitors both the activation of the patient's diaphragm (indicating patient respiratory effort) and the strength of this activation in, referred to as the electrical activity of the diaphragm (Edi) and measured in millivolts (µV). Both human and animal studies have positively correlated the peak Edi values with work-of-breathing and demonstrated higher Edi values when respiratory pathology is present . Based on the Edi tracing, the ventilator can then deliver positive inspiratory pressure that is synchronous with both the patient's respiratory effort and proportional to the strength of this effort through a multiplier referred to as the NAVA level on the ventilator. This modality has been shown to improve patient agitation levels, reduce the need for sedating medications, and enhance synchrony in non-invasive ventilation modes.

The current practice model of the investigators entails that patients with bronchiolitis who require more than 1.5 L/kg of HFNC or require non-invasive ventilation, whether via a conventional or NAVA modality, are managed in the Pediatric Intensive Care Unit (PICU). Both modalities for non-invasive ventilation (conventional and NAVA) are used routinely. Patient respiratory status is aggregated into a value known as the Respiratory Severity Score (RSS) which accounts for respiratory rate, dyspnea, retractions, and auscultatory findings adjusted for the age of the patient. The RSS value is a validated assessment tool with good interobserver reliability between Medical Doctors (MDs), Registered Nurses (RNs), and Respiratory Therapists (RTs). It is calculated on a 4-hour basis for all patients with bronchiolitis in the investigator's PICU and helps determine clinical improvement or deterioration and better guide decisions to increase or decrease support.

While multiple physiologic studies demonstrate a reduced work of breathing with invasive NAVA ventilation, the majority of pediatric studies focused on non-invasive NAVA ventilation were designed to determine improvements in patient/ventilator synchronization. The investigators' project aims are two-fold. The study team hypothesizes that Edi levels and RSS scores will positively correlate for patients with bronchiolitis, allowing for another metric to gauge clinical status. The investigators also hypothesizes that the improved synchronization on NAVA-NIV may improve respiratory status as measured by RSS scores and Edi levels, reduce further escalations in respiratory support, shorten the length of non-invasive ventilation required, and reduce intubation rates. This improvement will be more substantial when transitioning from HFNC to NAVA-NIV compared to transitioning to conventional-NIV.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Children's Hospital at Montefiore
        • Contact:
          • Timothy Brandt, MD
          • Phone Number: 718-619-7494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Non-Invasive Mechanical Servo Ventilation Arm
This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.
Device: Standard Non-Invasive Mechanical Servo Ventilation
The active comparator arm will utilize a standard non-invasive mode to provide ventilation support
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.
Device: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation
The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Respiratory Severity Score (RSS)
Time Frame: 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.
Approximately one hour after Edi catheter placement
Average Respiratory Severity Score (RSS)
Time Frame: 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.
48 hour average, values collected at ~4 hour intervals.
Baseline Electrical Activity of the Diaphragm (Edi)
Time Frame: 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.
Approximately one hour after Edi catheter placement
Average Baseline Electrical Activity of the Diaphragm (Edi)
Time Frame: 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.
48 hour average, values collected at ~4 hour intervals.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Non-Invasive Ventilation
Time Frame: Time of randomization or start of non-invasive ventilation (whichever occurs last) up to 4 weeks later or time of intubation (whichever occurs first)
The duration, in hours, that a patient requires non-invasive ventilation.
Time of randomization or start of non-invasive ventilation (whichever occurs last) up to 4 weeks later or time of intubation (whichever occurs first)
Number of participants requiring intubation
Time Frame: Following start of non-invasive ventilation or randomization (whichever comes last) up to 4 weeks later
If a patient requires intubation due to bronchiolitis, this information will be recorded
Following start of non-invasive ventilation or randomization (whichever comes last) up to 4 weeks later
Frequency of increasing ventilatory support
Time Frame: From hours 4-48 of the intervention period
The number of times that a physician increases respiratory support settings on the ventilator (other than FiO2) while remaining within protocol parameters will be documented. The number of events, limited to one event per hour, of increase in respiratory support will be counted during the study period. A greater number of increases in ventilatory support will indicate inadequate response to the treatment arm intervention.
From hours 4-48 of the intervention period
Number of patients requiring dexmedetomidine
Time Frame: Through 48 hour study intervention period
The number of patients requiring dexmedetomidine will be tabulated. The use of dexmedetomidine use likely reflects patient agitation and inability to ventilate adequately on non-invasive ventilation. The use of dexmedetomidine may indicate more agitation present within a given treatment arm.
Through 48 hour study intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Jacqueline Weingarten, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-14633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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