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Radiation-free lung scans could protect tiniest babies

NCT ID NCT06975189

Knowledge-focused Sponsor: Western Health, Australia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares lung ultrasound to standard chest X-rays in very preterm infants (born before 32 weeks) who need breathing support. The goal is to see if ultrasound can safely reduce the number of X-rays, lowering radiation exposure. About 180 babies will be randomly assigned to get either ultrasound or X-ray as the first imaging tool. If ultrasound works well, it could become a gentler way to monitor fragile 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 ultrasound (device)
What this could lead to
If successful, lung ultrasound could become a standard, radiation-free way to monitor preterm babies' lungs, reducing their lifetime radiation exposure.
What could go wrong
This is a Phase 2 trial with only 180 babies, so results may not apply to all preterm infants. Lung ultrasound might miss some details that X-rays catch, requiring additional imaging.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

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

Started

Apr 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 24 hours

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: All infants born \<32 weeks' gestation and admitted to the neonatal intensive care unit (NICU) who require lung imaging for respiratory indications will be considered eligible. Each infant must meet all the following criteria to be enrolled in this study: * The infant is born from 22 to 31+6 weeks' gestation by best obstetric estimate and admitted to the NICU * The infant is considered to require lung imaging for respiratory indications * The infant has a parent/guardian who can provide informed consent. Exclusion Criteria * The infant will only require CXR to be performed solely to confirm device position i.e. central line, endotracheal tube, gastric tubes * The infant will only require CXR to be performed for specifically for non-respiratory indications i.e. assessment of cardiac silhouette * The infant's Clinician has concern regarding clinical stability and tolerability of ultrasound scans * The infant's skin integrity will not tolerate ultrasound 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.

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome newborn respiratory distress syndrome Premature Birth Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Neonatal respiratory distress syndrome Preterm neonate

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, Sunshine Hospital, Western Health

    RECRUITING

    Melbourne, Victoria, 3021, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.