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Smarter breathing machine may help sick babies breathe easier

NCT ID NCT06053684

Symptom relief Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two types of non-invasive breathing support for infants under 2 years old with bronchiolitis in the pediatric ICU. One method uses standard ventilation, while the other uses a smarter mode called NAVA that synchronizes with the baby's own breathing. The goal is to see if NAVA improves comfort and reduces the need for a breathing tube.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Neurally-Adjusted Ventilatory Assistance (NAVA) non-invasive ventilation
What this could lead to
If it works, this could lead to a more comfortable breathing support method for infants with bronchiolitis, potentially reducing the need for more invasive procedures like intubation.
What could go wrong
This is a relatively small, early-stage trial (130 participants) comparing two ventilation modes, so results may not apply to all patients. The improvement in comfort may not translate to major clinical benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bronchiolitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiolitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital at Montefiore

    RECRUITING

    The Bronx, New York, 10467, United States

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