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Oxygen dilemma: which level saves preterm brains?

NCT ID NCT03825835

Disease control Sponsor: University of Alberta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 1 time

Summary

This study compares using 30% versus 60% oxygen when resuscitating extremely preterm babies (born before 29 weeks). The goal is to see which oxygen level leads to better survival and fewer long-term developmental problems like cerebral palsy or vision/hearing loss. About 1,200 babies across multiple hospitals will take part, with each hospital switching between the two oxygen levels over time.

What this could mean

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

Active substance
oxygen
What this could lead to
If it works, this could establish the safest oxygen level to use when resuscitating extremely preterm babies, potentially reducing death and long-term brain injury.
What could go wrong
This is a large trial but still testing a common practice; the difference between 30% and 60% oxygen may be small, and results may not apply to all hospitals or babies.

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 1,200 people

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

Started

Jun 2022

Expected to finish

Dec 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

0 to 10 minutes

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: * Infants born at 23 0/7 weeks to 28 6/7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities Exclusion Criteria: * Infants who are outborn - initial resuscitation not performed at the study centre * Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants * Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes * Infants who will not receive full resuscitation at birth- these infants will not receive resuscitation

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Conditions

The condition(s) this trial relates to.

Premature Birth respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Neurodevelopmental outcome Premature infant Respiratory distress syndrome in premature infant

How to take part

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

  1. The places running it

    2 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

  • BC Children

    ACTIVE_NOT_RECRUITING

    Vancouver, British Colubia, Canada

  • CHEO

    ACTIVE_NOT_RECRUITING

    Ottawa, Ontario, Canada

  • Chu University Laval

    ACTIVE_NOT_RECRUITING

    Québec, Quebec, Canada

  • Foothills Hospital

    ACTIVE_NOT_RECRUITING

    Calgary, Alberta, Canada

  • Health Sciences

    RECRUITING

    Winnipeg, Manitoba, Canada

  • Hospital Germans Tries i Pujol

    WITHDRAWN

    Barcelona, Spain

  • Hospital Las Palmas

    WITHDRAWN

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario Dexeus

    WITHDRAWN

    Barcelona, Spain

  • Hospital Universitario Materno Infantil Miguel Servet

    WITHDRAWN

    Zaragoza, Spain

  • Hospital de Asturias

    WITHDRAWN

    Oviedo, Spain

  • Hospital de la Arrixaca

    WITHDRAWN

    El Palmar, Spain

  • Janeway Children's Health and Rehabilitation Centre

    ACTIVE_NOT_RECRUITING

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • McGill Univeristy

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, Canada

  • Neonatal Intensive Care Unit - Hamilton Health Sciences

    ACTIVE_NOT_RECRUITING

    Hamilton, Ontario, L8S 4K1, Canada

  • Neonatal Intensive Care Unit - Mount Sinai Hospital

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, Canada

  • Newborn Health - IWK Health Centre

    ACTIVE_NOT_RECRUITING

    Halifax, Nova Scotia, Canada

  • Queen's University

    WITHDRAWN

    Kingston, Ontario, K7L 3N6, Canada

  • Royal Alexandra Hospital

    ACTIVE_NOT_RECRUITING

    Edmonton, Alberta, T5H 3V9, Canada

  • Sunnybrook Health Sciences Centre

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, Canada

  • University College Cork

    RECRUITING

    Cork, Ireland

  • Université de Sherbrooke

    ACTIVE_NOT_RECRUITING

    Sherbrooke, Quebec, J1N 3C6, Canada

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