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Slower lung inflation may protect preterm Babies' lungs

NCT ID NCT07101419

Symptom relief 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial studies whether a slower inflation setting (long pressure rise time) on mechanical ventilators can improve oxygen levels in extremely preterm infants compared to the standard faster setting. About 68 babies born before 28 weeks will be randomly assigned to both settings in a crossover design. The goal is to find a gentler way to support breathing and reduce lung damage.

What this could mean

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

Active substance
mechanical ventilator setting (pressure rise time)
What this could lead to
If it works, this could lead to a gentler ventilator setting that reduces lung damage in extremely preterm babies.
What could go wrong
This is a small, early-stage crossover trial with only 68 infants, so results may not apply broadly. The intervention is a temporary setting change, not a cure or long-term treatment.

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 68 people

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

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Feb 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

6 hours to 7 days

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: * Admitted to participating neonatal intensive care unit * Born between 22+0 to 27+6 weeks' gestation * Current weight ≥400 grams * Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee \[PC-AC+VG\] mode on Dräger Babylog VN500/800 ventilators) initiated within 72-hours post birth * Postnatal age ≥6 hours and ≤7 days * Received surfactant therapy * Clinically stable (as per treating and research team consensus) * Parent(s)/legal guardian provides prospective informed consent. Exclusion Criteria: * Major congenital anomaly involving the cardiac, respiratory or 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 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life * Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation * Planned for extubation from mechanical ventilation within the next 12 hours.

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome respiratory distress syndrome in premature infants Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Respiratory distress syndrome in premature infant Respiratory distress syndrome, newborn

How to take part

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

  1. The places running it

    3 sites. 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

    Saint Albans, Victoria, 3021, Australia

  • Mercy Hospital for Women

    Heidelberg, Victoria, Australia

  • The Royal Women's Hospital

    Parkville, Victoria, 3051, Australia

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