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New breathing mode tested in tiny infants with severe lung condition

NCT ID NCT04821453

Symptom relief Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested two different ways of using a breathing machine (ventilator) in 12 premature infants with severe bronchopulmonary dysplasia (BPD), a serious lung condition. One mode, called NAVA, uses the baby's own diaphragm signals to trigger breaths, while the other, CMV, uses airflow. The goal was to see if NAVA improves oxygen levels and reduces the need for sedation. The trial was stopped early, so results are limited.

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 Assist (NAVA) mode of mechanical ventilation
What this could lead to
If successful, this could show that NAVA is a better way to support breathing in infants with severe lung disease, potentially improving oxygen levels and reducing stress.
What could go wrong
This was a very small pilot study (12 infants) that was terminated early, so results are limited. It may not show a clear benefit over standard ventilation.

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

12 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2025

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

Up to 24 months

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: 1. Gestational ages (GA) ≤ 32 weeks 2. Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age 3. Severe BPD \[as per National Institutes of Health (NIH) consensus definition\] diagnosed at 36 weeks postmenstrual age 4. Receiving invasive mechanical ventilation for ongoing lung disease 5. Not expected to be ready for extubation within 11 days following enrollment 6. Parental consent Exclusion Criteria: 1. Severe congenital anomalies 2. Known diaphragmatic defect 3. Current treatment with high frequency mechanical ventilation 4. Do not resuscitate (DNR) Status or Futility of Care 5. \>10% leak around the artificial airway, 6. Treatment with neuromuscular blockade within 72 hours prior to enrollment 7. Acute respiratory instability defined as a ventilator rate increase \> 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase \> 2 cm/water (H2O), sustained FiO2 increase \> 20%, and/or prescribed increase in tidal volume \> 2 mL/kg within 24 hours prior to enrollment will be excluded.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia

As listed by the trial registrant

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

Bronchopulmonary dysplasia Mechanical ventilation Neurally adjusted ventilatory assist

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Rhode Island Hospital (Hasboro Children's Hospital)

    Providence, Rhode Island, 02903, United States

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