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Could a quick CPAP boost help preterm babies breathe better?

NCT ID NCT07522346

Knowledge-focused 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 09, 2026 · Updated 7 times

Summary

This study tests whether briefly increasing the air pressure from a CPAP machine before giving surfactant therapy helps preterm babies' lungs work better. Surfactant is a natural substance that helps immature lungs stay open, and it's often given through a thin tube. The trial will compare this 'lung recruitment' approach to standard care in 36 infants born between 24 and 32 weeks. The goal is to see if the simple pressure change improves how evenly air spreads in the lungs.

What this could mean

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

Active substance
Lung recruitment manoeuvre (increased CPAP pressure) before minimally invasive surfactant therapy
What this could lead to
If it works, this could point toward a simple way to make surfactant therapy more effective for preterm babies, potentially reducing the need for more breathing support.
What could go wrong
This is a very small, early study (36 infants) looking at lung patterns, not long-term outcomes. The intervention is brief and may not show clear benefits or could cause temporary discomfort.

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 36 people

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

Started

Aug 2026

Expected to finish

Apr 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

24 to 32 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: * Born between 24 to 31+6 weeks' gestation, by best obstetric estimate * Admitted to a participating NICU * A parent/guardian who can provide informed consent * Receiving CPAP respiratory support * Planned to receive MIST by clinicians as standard clinical care * Clinically stable (as determined by clinical team) * Infant less than 72 hours of age * MIST can be administered within 90 min of allocating assigned interventional arm Exclusion Criteria: * Receiving any form of respiratory support other than CPAP * Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth) * The infant's clinical team has concern regarding clinical stability and tolerability of EIT * The infant's skin integrity will not tolerate the EIT belt and gel * Refusal of informed consent by their parent/guardian/legally acceptable representative * The infant does not have a parent/guardian who can provide informed consent. * Major congenital anomaly involving the cardiac, respiratory, gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes * Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 24 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early post-natal life * Suspected or confirmed air leak or pneumothorax * Previous treatment with surfactant or mechanical ventilation via an endotracheal tube * Urgent need for intubation and mechanical ventilation as determined by the treating clinician * Not receiving full active intensive care (i.e. palliative/comfort care)

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Pulmonary Atelectasis respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Surfactant deficiency syndrome neonatal

How to take part

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

  1. The places running it

    1 site. 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

  • Joan Kirner Women's and Children's Hospital

    RECRUITING

    Saint Albans, Victoria, 3021, Australia

More trials for these conditions

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