Actively Recruiting

Phase Not Applicable
Age: 0Years - 2Years
All Genders
NCT06053684

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

Led by Montefiore Medical Center · Updated on 2025-09-05

130

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0Years - 2Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

J

Jacqueline Weingarten, MD

CONTACT

M

Monica Koncicki, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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