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

NCT06053684 | Recruiting DMC FDA Device

• 1 other identifier: 2023-14633
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  48 hour average, values collected at ~4 hour intervals.

Secondary Outcomes (4)

• Duration of 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

  Following start of non-invasive ventilation or randomization (whichever comes last) up to 4 weeks later

• Frequency of increasing ventilatory support

  From hours 4-48 of the intervention period

• Number of patients requiring dexmedetomidine

  Through 48 hour study intervention period

Study Arms (2)

Standard Non-Invasive Mechanical Servo Ventilation Arm

ACTIVE COMPARATOR

This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.

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.

Device: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation

Interventions

Standard Non-Invasive Mechanical Servo Ventilation DEVICE

The active comparator arm will utilize a standard non-invasive mode to provide ventilation support

Standard Non-Invasive Mechanical Servo Ventilation Arm

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

Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 30740281 BACKGROUND

• Javouhey 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.

  PMID: 18500424 BACKGROUND

• Morley 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.

  PMID: 27118355 BACKGROUND

• Jones 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.

  PMID: 30254048 BACKGROUND

• Pham 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.

  PMID: 24846750 BACKGROUND

• Alander 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.

  PMID: 21830318 BACKGROUND

• Kallio 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.

  PMID: 24482284 BACKGROUND

• Ducharme-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.

  PMID: 25886793 BACKGROUND

• Liu 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.

  PMID: 14966818 BACKGROUND

• Duyndam 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.

  PMID: 23419184 BACKGROUND

• Stein 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.

  PMID: 23636099 BACKGROUND

• Beck 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.

  PMID: 26375790 BACKGROUND

• Vignaux 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.

  PMID: 23863816 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Jacqueline Weingarten, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Weingarten, MD

CONTACT

2017459825; jweingar@montefiore.edu

Monica Koncicki, MD

CONTACT

mkoncicki@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 26, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)