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Baby breathing breakthrough? study tests oxygen flow in intubation

NCT ID NCT05967507

Knowledge-focused Sponsor: Thomas Riva 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether using a low flow of oxygen during a breathing tube placement in babies works as well as a high flow. About 1,192 newborns and infants up to 52 weeks old will take part. The goal is to see if the first attempt at placing the tube is just as successful with less oxygen.

What this could mean

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

Active substance
supplemental oxygen (low-flow vs high-flow)
What this could lead to
If low-flow oxygen works as well as high-flow, it could simplify and reduce costs for infant intubation procedures.
What could go wrong
This is an early-stage study comparing two oxygen delivery methods, not testing a new treatment. Results may show no meaningful difference or that low-flow is less safe.

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 1,192 people

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

Started

Dec 2023

Expected to finish

Sep 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

Up to 52 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: * Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical indications. * Neonates and infants up to 52 weeks postconceptual age, with legal guardians providing written informed consent before the intervention Exclusion Criteria: * Prediction of difficult intubation upon physical examination or previous history of difficult intubation, mandating a technique different than direct laryngoscopy to secure the airway; * Congenital heart disease demanding FiO2 \< 1.0 * Cardiopulmonary collapse requiring advanced life support * Intubation for emergency surgical and non-surgical indications.

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As listed by the trial registrant

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

Airway management

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 7 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

  • CHUV Centre Hospitalier Universitaire Vaudois

    ACTIVE_NOT_RECRUITING

    Lausanne, 1011, Switzerland

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedizin

    RECRUITING

    Berlin, Germany

  • Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre

    RECRUITING

    Montreal, Canada

  • Dept. Anesthesia, The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, Canada

  • Hospital Municipal Infantil Menino Jesus, Servicos Medicos de Anestesia

    RECRUITING

    São Paulo, São Paulo, Brazil

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genova, 16147, Italy

  • Inselspital

    RECRUITING

    Bern, 3010, Switzerland

  • Kantonsspital Aarau, KSA

    RECRUITING

    Aarau, Canton of Aargau, Switzerland

  • Luzerner Kantonsspital

    RECRUITING

    Lucerne, Canton of Lucerne, 6004, Switzerland

  • Perth Children's Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

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