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Which PEEP level saves preemie lungs? major trial seeks answer

NCT ID NCT04372953

Disease control Sponsor: Murdoch Childrens Research Institute 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two ways of giving breathing support (PEEP) to very premature babies right after birth. One method uses a steady pressure, the other starts high then lowers it. The goal is to see which approach reduces the chance of death or chronic lung disease. Over 900 babies born between 23 and 28 weeks are taking part.

What this could mean

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

Active substance
Positive End-Expiratory Pressure (PEEP) via CPAP or ventilation
What this could lead to
If it works, this could identify the best way to support premature babies' breathing at birth, potentially reducing death or long-term lung disease.
What could go wrong
This is a large trial but still early-stage for clinical practice. The two PEEP strategies may show no clear difference, and results may not apply to all preterm infants.

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 906 people

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

Started

May 2021

Expected to finish

May 2028

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

23 to 28 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: * Infants born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate). * Receives respiratory intervention (resuscitation) at birth with CPAP and/or positive pressure ventilation in the Delivery Room, to support transition and/or respiratory failure related to prematurity. * Has a parent or other legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf either prospectively or after birth and randomisation if prenatal consent was not possible (at sites where the Ethics Committee permits waiver of prospective consent). Exclusion Criteria: * Not for active care based on assessment of the attending clinician or family decision * Anticipated severe pulmonary hypoplasia due to rupture of membranes \<22 weeks with anhydramnios or fetal hydrops * Major congenital anomaly or anticipated alternative cause for respiratory failure * Refusal of informed consent by their legally acceptable representative * Does not have a guardian who can provide informed consent.

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Conditions

The condition(s) this trial relates to.

acute lung injury bronchopulmonary dysplasia Lung Injury Premature Birth

As listed by the trial registrant

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

Lung injury Preterm birth

Contacts and locations

Locations

  • Academic Teaching Hospital

    Feldkirch, 6800, Austria

  • Amalia Children's Hospital Radboudumc

    Nijmegen, 6500, Netherlands

  • Amsterdam University Medical Centre

    Amsterdam, 1105, Netherlands

  • Antoine Beclere Medical Center / South Paris University Hospitals

    Paris, France

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS, United Kingdom

  • Careggi Hospital

    Florence, Italy

  • Filippo del Ponte Hospital

    Varese, Milan, 21100, Italy

  • Gemelli University Hospital

    Rome, Italy

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Indiana University / Riley Children Health at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • James Cook University Hospital

    Middlesbrough, England, United Kingdom

  • Joan Kirner Women & Children's Hospital - VIC

    Melbourne, Victoria, 3021, Australia

  • King Edward Memorial Hospital

    Subiaco, Western Australia, 6008, Australia

  • Mater Misericordiae

    South Brisbane, Queensland, 4101, Australia

  • Maxima Medical Centre

    Veldhoven, 5504, Netherlands

  • Ospedale Maggiore Policlinico

    Milan, Italy

  • Royal Hospital for Children

    Glasgow, Scotland, United Kingdom

  • Royal Infirmary Edinburgh

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • San Gerardo Hospital

    Monza, Milan, 20090, Italy

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

  • Southmead Hospital

    Bristol, England, United Kingdom

  • The Royal Women's Hospital, Melbourne Australia

    Parkville, Victoria, 3052, Australia

  • University Hospital Wishaw

    Wishaw, Scotland, United Kingdom

  • University Hospitals Leicester

    Leicester, United Kingdom

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • Vittore Buzzi Children's Hospital / Ospedale dei Bambini

    Milan, Italy

  • Women & Childrens Hospital Adelaide

    Adelaide, South Australia, Australia

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