BronchiolitisNCT06053684
Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis
A study testing Standard Non-Invasive Mechanical Servo Ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation in people with Bronchiolitis, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Standard Non-Invasive Mechanical Servo Ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- Standard Non-Invasive Mechanical Servo Ventilation, Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Non-Invasive Mechanical Servo VentilationDevice
The active comparator arm will utilize a standard non-invasive mode to provide ventilation support
Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo VentilationDevice
The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support
| Study group | Role | What they receive |
|---|---|---|
| Standard Non-Invasive Mechanical Servo Ventilation Arm | Active comparator | This arm will utilize a standard mode of non-invasive ventilation within protocol parameters. Receives: Device: Standard Non-Invasive Mechanical Servo Ventilation |
| Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm | Experimental | This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters. Receives: Device: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Respiratory Severity Score (RSS)
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.
Measured: Approximately one hour after Edi catheter placement
Average Respiratory Severity Score (RSS)
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.
Measured: 48 hour average, values collected at ~4 hour intervals.
Baseline Electrical Activity of the Diaphragm (Edi)
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.
Measured: Approximately one hour after Edi catheter placement
Average Baseline Electrical Activity of the Diaphragm (Edi)
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.
Measured: 48 hour average, values collected at ~4 hour intervals.
Secondary outcomes (4)
Duration of Non-Invasive Ventilation
The duration, in hours, that a patient requires non-invasive ventilation.
Measured: 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
If a patient requires intubation due to bronchiolitis, this information will be recorded
Measured: Following start of non-invasive ventilation or randomization (whichever comes last) up to 4 weeks later
Frequency of increasing ventilatory support
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.
Measured: From hours 4-48 of the intervention period
Number of patients requiring dexmedetomidine
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.
Measured: Through 48 hour study intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start18 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Study suspended pending outcome of discussions among IRB, PI, and DSMC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Weingarten, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053684
- Sponsor's protocol ID
- 2022-14633
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lodeserto FJ, Lettich TM, Rezaie SR. High-flow Nasal Cannula: Mechanisms of Action and Adult and Pediatric Indications. Cureus. 2018 Nov 26;10(11):e3639. doi: 10.7759/cureus.3639.
PubMed 30740281Javouhey E, Barats A, Richard N, Stamm D, Floret D. Non-invasive ventilation as primary ventilatory support for infants with severe bronchiolitis. Intensive Care Med. 2008 Sep;34(9):1608-14. doi: 10.1007/s00134-008-1150-4. Epub 2008 May 24.
PubMed 18500424Morley SL. Non-invasive ventilation in paediatric critical care. Paediatr Respir Rev. 2016 Sep;20:24-31. doi: 10.1016/j.prrv.2016.03.001. Epub 2016 Mar 14.
PubMed 27118355Jones ML, Bai S, Thurman TL, Holt SJ, Heulitt MJ, Courtney SE. Comparison of Work of Breathing Between Noninvasive Ventilation and Neurally Adjusted Ventilatory Assist in a Healthy and a Lung-Injured Piglet Model. Respir Care. 2018 Dec;63(12):1478-1484. doi: 10.4187/respcare.06192. Epub 2018 Sep 25.
PubMed 30254048Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
PubMed 24846750Alander M, Peltoniemi O, Pokka T, Kontiokari T. Comparison of pressure-, flow-, and NAVA-triggering in pediatric and neonatal ventilatory care. Pediatr Pulmonol. 2012 Jan;47(1):76-83. doi: 10.1002/ppul.21519. Epub 2011 Aug 9.
PubMed 21830318Kallio M, Peltoniemi O, Anttila E, Pokka T, Kontiokari T. Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. Pediatr Pulmonol. 2015 Jan;50(1):55-62. doi: 10.1002/ppul.22995. Epub 2014 Jan 31.
PubMed 24482284Ducharme-Crevier L, Beck J, Essouri S, Jouvet P, Emeriaud G. Neurally adjusted ventilatory assist (NAVA) allows patient-ventilator synchrony during pediatric noninvasive ventilation: a crossover physiological study. Crit Care. 2015 Feb 17;19(1):44. doi: 10.1186/s13054-015-0770-7.
PubMed 25886793Liu LL, Gallaher MM, Davis RL, Rutter CM, Lewis TC, Marcuse EK. Use of a respiratory clinical score among different providers. Pediatr Pulmonol. 2004 Mar;37(3):243-8. doi: 10.1002/ppul.10425.
PubMed 14966818Duyndam A, Bol BS, Kroon A, Tibboel D, Ista E. Neurally adjusted ventilatory assist: assessing the comfort and feasibility of use in neonates and children. Nurs Crit Care. 2013 Mar-Apr;18(2):86-92. doi: 10.1111/j.1478-5153.2012.00541.x. Epub 2012 Nov 22.
PubMed 23419184Stein H, Hall R, Davis K, White DB. Electrical activity of the diaphragm (Edi) values and Edi catheter placement in non-ventilated preterm neonates. J Perinatol. 2013 Sep;33(9):707-11. doi: 10.1038/jp.2013.45. Epub 2013 May 2.
PubMed 23636099Beck J, Emeriaud G, Liu Y, Sinderby C. Neurally-adjusted ventilatory assist (NAVA) in children: a systematic review. Minerva Anestesiol. 2016 Aug;82(8):874-83. Epub 2015 Sep 16.
PubMed 26375790Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Levy-Jamet Y, Jaecklin T, Tourneux P, Jolliet P, Rimensberger PC. Patient-ventilator asynchrony during noninvasive pressure support ventilation and neurally adjusted ventilatory assist in infants and children. Pediatr Crit Care Med. 2013 Oct;14(8):e357-64. doi: 10.1097/PCC.0b013e3182917922.
PubMed 23863816
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Non-Invasive Ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Ventilation for the Treatment of Bronchiolitis
- ClinicalTrials.gov ID
- NCT06053684
- Acronym / sponsor ID
- 2022-14633
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended pending outcome of discussions among IRB, PI, and DSMC
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Non-Invasive Mechanical Servo Ventilation Arm | Active comparator | Device: Standard Non-Invasive Mechanical Servo VentilationThis arm will utilize a standard mode of non-invasive ventilation within protocol parameters. |
| Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm | Experimental | Device: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo VentilationThis arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters. |
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Non-Invasive Mechanical Servo VentilationThe active comparator arm will utilize a standard non-invasive mode to provide ventilation support | Device | Standard Non-Invasive Mechanical Servo Ventilation Arm |
| Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo VentilationThe experimental arm will utilize a NAVA mode to provide non-invasive ventilation support | Device | Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
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)
Number of participants requiring intubation
Time frame: 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
Number of patients requiring dexmedetomidine
Time frame: Through 48 hour study intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 30740281Lodeserto FJ, Lettich TM, Rezaie SR. High-flow Nasal Cannula: Mechanisms of Action and Adult and Pediatric Indications. Cureus. 2018 Nov 26;10(11):e3639. doi: 10.7759/cureus.3639.
- Background: PubMed 18500424Javouhey E, Barats A, Richard N, Stamm D, Floret D. Non-invasive ventilation as primary ventilatory support for infants with severe bronchiolitis. Intensive Care Med. 2008 Sep;34(9):1608-14. doi: 10.1007/s00134-008-1150-4. Epub 2008 May 24.
- Background: PubMed 27118355Morley SL. Non-invasive ventilation in paediatric critical care. Paediatr Respir Rev. 2016 Sep;20:24-31. doi: 10.1016/j.prrv.2016.03.001. Epub 2016 Mar 14.
- Background: PubMed 30254048Jones ML, Bai S, Thurman TL, Holt SJ, Heulitt MJ, Courtney SE. Comparison of Work of Breathing Between Noninvasive Ventilation and Neurally Adjusted Ventilatory Assist in a Healthy and a Lung-Injured Piglet Model. Respir Care. 2018 Dec;63(12):1478-1484. doi: 10.4187/respcare.06192. Epub 2018 Sep 25.
- Background: PubMed 24846750Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
- Background: PubMed 21830318Alander M, Peltoniemi O, Pokka T, Kontiokari T. Comparison of pressure-, flow-, and NAVA-triggering in pediatric and neonatal ventilatory care. Pediatr Pulmonol. 2012 Jan;47(1):76-83. doi: 10.1002/ppul.21519. Epub 2011 Aug 9.
- Background: PubMed 24482284Kallio M, Peltoniemi O, Anttila E, Pokka T, Kontiokari T. Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. Pediatr Pulmonol. 2015 Jan;50(1):55-62. doi: 10.1002/ppul.22995. Epub 2014 Jan 31.
- Background: PubMed 25886793Ducharme-Crevier L, Beck J, Essouri S, Jouvet P, Emeriaud G. Neurally adjusted ventilatory assist (NAVA) allows patient-ventilator synchrony during pediatric noninvasive ventilation: a crossover physiological study. Crit Care. 2015 Feb 17;19(1):44. doi: 10.1186/s13054-015-0770-7.
- Background: PubMed 14966818Liu LL, Gallaher MM, Davis RL, Rutter CM, Lewis TC, Marcuse EK. Use of a respiratory clinical score among different providers. Pediatr Pulmonol. 2004 Mar;37(3):243-8. doi: 10.1002/ppul.10425.
- Background: PubMed 23419184Duyndam A, Bol BS, Kroon A, Tibboel D, Ista E. Neurally adjusted ventilatory assist: assessing the comfort and feasibility of use in neonates and children. Nurs Crit Care. 2013 Mar-Apr;18(2):86-92. doi: 10.1111/j.1478-5153.2012.00541.x. Epub 2012 Nov 22.
- Background: PubMed 23636099Stein H, Hall R, Davis K, White DB. Electrical activity of the diaphragm (Edi) values and Edi catheter placement in non-ventilated preterm neonates. J Perinatol. 2013 Sep;33(9):707-11. doi: 10.1038/jp.2013.45. Epub 2013 May 2.
- Background: PubMed 26375790Beck J, Emeriaud G, Liu Y, Sinderby C. Neurally-adjusted ventilatory assist (NAVA) in children: a systematic review. Minerva Anestesiol. 2016 Aug;82(8):874-83. Epub 2015 Sep 16.
- Individual participant dataSharing planned: No
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A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Weingarten, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Non-Invasive Mechanical Servo Ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation in people with Bronchiolitis, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Respiratory Severity Score (RSS) (time frame: Approximately one hour after Edi catheter placement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053684, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.