Recruiting

Non-Invasive Ventilation vs. NAVA

Sponsor:

Montefiore Medical Center

Code:

NCT06053684

Conditions

Bronchiolitis

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Standard Non-Invasive Mechanical Servo Ventilation

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

Study Details

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

Study ID

NCT06053684

Start date

Dec 18, 2023

Status verified date

Aug, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Standard Non-Invasive Mechanical Servo Ventilation

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

The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jacqueline Weingarten, MD

2017459825jweingar@montefiore.edu

Monica Koncicki, MD

mkoncicki@montefiore.org

Locations

Children's Hospital at Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Timothy Brandt, MD

718-619-7494

More Information

Sponsor

Montefiore Medical Center

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-09-05.