Actively Recruiting

Phase Not Applicable
Age: 0Years - 2Years
All Genders
ID06053684

Comparison of Conventional and Neurally-Adjusted Ventilatory Assistance Non-Invasive Ventilation for Treating Bronchiolitis in Children Under 2 Years

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

130

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out if using Neurally-Adjusted Ventilatory Assistance (NAVA) mode for non-invasive ventilation in children with bronchiolitis improves their comfort and reduces the need for more intense treatments like intubation compared to standard non-invasive ventilation. Bronchiolitis is a common lung infection in young children that can cause breathing difficulties. NAVA has been shown to better match the ventilator support with the child's breathing efforts, which may lead to better breathing support. The study compares two non-invasive ventilation methods: the standard mode and the NAVA mode. The NAVA method uses a special catheter placed in the esophagus to monitor the electrical activity of the diaphragm, allowing the ventilator to deliver pressure that matches the child's breathing effort more closely. Children will receive either standard non-invasive ventilation or NAVA ventilation according to the study protocol while in the Pediatric Intensive Care Unit. The researchers will track breathing scores and diaphragm activity to see how these methods affect breathing support and comfort. Participants will be monitored regularly for their respiratory status using a Respiratory Severity Score (RSS) and measurements of electrical activity in the diaphragm (Edi). These assessments are taken about one hour after placing the catheter and then approximately every four hours over a 48-hour period. The study will also observe how long children need non-invasive ventilation, if they require intubation, and any need for increased ventilatory support or sedating medications. The study period lasts up to four weeks or until intubation if needed.

CONDITIONS

Brief 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 due to high oxygen needs, high carbon dioxide levels, frequent apneas, or clinical judgment
  • Patients with hemodynamic instability requiring vasoactive medication

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 weeks or until intubation

Participants receive either standard non-invasive mechanical ventilation or neurally-adjusted ventilatory assistance (NAVA) non-invasive ventilation to support breathing during bronchiolitis.

Continuous monitoring in the Pediatric Intensive Care Unit during ventilation support

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

M

Monica Koncicki, MD

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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Published Research Related To This Trial

Comparison of Work of Breathing Between Noninvasive Ventilation and Neurally Adjusted Ventilatory Assist in a Healthy and a Lung-Injured Piglet Model.

Michelle L Jones, Shasha Bai, Tracy L Thurman...

https://pubmed.ncbi.nlm.nih.gov/30254048

Neurally adjusted ventilatory assist (NAVA) allows patient-ventilator synchrony during pediatric noninvasive ventilation: a crossover physiological study.

Laurence Ducharme-Crevier, Jennifer Beck, Sandrine Essouri...

https://pubmed.ncbi.nlm.nih.gov/25886793