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New breathing device could help tiny preemies stay off ventilators

NCT ID NCT05446272

Disease control Sponsor: University of Pennsylvania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether a new breathing support method called NIV-NAVA helps very preterm infants (born at 23-28 weeks) avoid breathing failure after being taken off a ventilator. About 478 infants will be randomly assigned to receive either NIV-NAVA or standard non-synchronized NIPPV. The main goal is to see if NIV-NAVA reduces the need for re-intubation within 5 days.

What this could mean

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

Active substance
Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) device
What this could lead to
If successful, this could provide a better way to support breathing in preterm infants after they are taken off a ventilator, reducing the need for re-intubation and possibly lowering the risk of lung damage.
What could go wrong
This is a single trial, and results may not apply to all hospitals or infants. The device requires specialized training, and there is always a chance it does not improve outcomes compared to standard care.

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 478 people

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

Started

Aug 2022

Expected to finish

Dec 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 days to 9 weeks

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: * Gestational age of 23 0/7- 28 6/7 weeks at birth * Intubated in the first 7 days of life * Undergoing extubation following at least 12 hours of invasive mechanical ventilation * Post-natal age \<32 weeks Post menstrual age at time of extubation Exclusion Criteria: * Major congenital anomalies, including pulmonary hypoplasia * Neurologic disorders affecting respiratory drive (other than apnea of prematurity) * Esophageal bleeding or other contraindication to NG/OG catheter placement * Current weight \<500 grams (based on Edi catheter approval) * Study ventilator not available at time eligibility criteria are met * Planned surgery or invasive procedure within 5 days of extubation * Informed consent not provided

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia Death

As listed by the trial registrant

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

Bronchopulmonary dysplasia Death Extubation failure

How to take part

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

  1. The places running it

    19 sites in 2 countries. 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

  • AdventHealth

    RECRUITING

    Orlando, Florida, 32803, United States

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Atrial Health Brenner Children's Hospital( Wake Forest)

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • BC Children's and Women's Hospital

    RECRUITING

    Vancouver, BC V6H 3N1, Canada

  • Children's Hospital of Richmond

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Levine Children's Hospital

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Loma Linda University

    TERMINATED

    Loma Linda, California, 92350, United States

  • Mt Sinai Hospital

    RECRUITING

    Toronto, ON M5G 1X5, Canada

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Peyton Manning Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Sharp Mary Birch

    RECRUITING

    San Diego, California, 92123, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N3M5, Canada

  • Utah Valley Hospital

    RECRUITING

    Provo, Utah, 84604, United States

  • Virtua Vorhees Hospital

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • Washington University in St.Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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