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New ventilator method may save fragile preemies from breathing tubes

NCT ID NCT06849596

Disease control Sponsor: Michelle Baczynski 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to help extremely premature babies (born at 25-28 weeks) breathe right after birth. One method uses a standard manual T-piece device; the other uses a ventilator to deliver gentle puffs of air through a nasal mask. The goal is to see if the ventilator approach reduces the chance of death or serious complications like brain injury or chronic lung disease. About 780 babies will take part across multiple hospitals.

What this could mean

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

Active substance
Ventilator-derived positive pressure ventilation (V-PPV) via nasal mask
What this could lead to
If it works, this could lead to a better way to help extremely premature babies breathe right after birth, reducing the need for a breathing tube and lowering the risk of death or brain injury.
What could go wrong
This is a relatively early-stage trial, and the ventilator method may not prove better than the standard T-piece. The babies are extremely fragile, so any breathing support carries risks.

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 780 people

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

Started

Dec 2025

Expected to finish

Jan 2029

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

25 to 29 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:: * GA 25+0 to 28+6 weeks using the best available obstetrical estimate * Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care * Received PPV as determined by the resuscitation team during the first 10 minutes of birth Exclusion Criteria: * Outborn birth status * Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward) * Known major congenital or chromosomal anomaly * Established spontaneous respiration without receipt of PPV

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Conditions

The condition(s) this trial relates to.

apnea of prematurity Lung Injury Premature Birth Respiratory Aspiration

As listed by the trial registrant

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

Apnea neonatal Neonatal resuscitation

How to take part

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

  1. The places running it

    10 sites in 3 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

  • BC Children's and Women's Hospital

    NOT_YET_RECRUITING

    Vancouver, British Columbia, Canada

  • CHU Sainte Justine

    RECRUITING

    Montreal, Quebec, Canada

  • Cedars-Sinai Guerin Children's

    RECRUITING

    Los Angeles, California, 90505, United States

  • Children's Hospital at London Health Sciences Centre

    NOT_YET_RECRUITING

    London, Ontario, Canada

  • Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, Canada

  • McMaster Children's Hospital

    RECRUITING

    Hamilton, Ontario, Canada

  • Montreal Children's Hospital

    RECRUITING

    Montral, Quebec, Canada

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • Rigshospitalet Coppenhagen

    NOT_YET_RECRUITING

    Copenhagen, Denmark

  • Royal Alexandra Hospital

    RECRUITING

    Edmonton, Alberta, Canada

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