Minimizing radiation exposure in very preterm babies
Official title: Lung Ultrasound to Reduce the Number of Chest X-rays in Very Preterm Infants in the First 2 Weeks After Birth: A Randomised Controlled Trial
Run by Western Health, Australia · NCT06975189 · Data updated 2026-11-12
This trial will try using bedside lung ultrasound instead of routine chest X-rays to guide breathing support for babies born before 32 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 24 Hours |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Western Health, Australia Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Melbourne, Victoria) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | August 1, 2029 |
| Study ends | December 1, 2029 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06975189 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born between 22 and 31+6 weeks' gestation who are admitted to the NICU, require lung imaging for respiratory reasons, and have a parent or guardian able to give informed consent are ideal candidates.
✕Probably not a fit
Babies who only need chest X-rays for non-respiratory reasons (such as device placement or cardiac assessment), or those whose skin or clinical stability prevents ultrasound, are unlikely to benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional trial compares care guided by lung ultrasound with standard care that relies on chest X-rays in very preterm infants. Eligible infants (22 to 31+6 weeks' gestation) admitted to the NICU who require lung imaging will be enrolled with parental consent and allocated to either the lung ultrasound group or standard care. Lung ultrasound is radiation-free and can be performed at the bedside to provide more frequent, real-time information about lung status. The study will measure radiation exposure and short-term respiratory management outcomes while monitoring safety and tolerability.
Why it matters
Potential benefit: If successful, this approach could substantially reduce radiation exposure and provide faster, bedside lung monitoring that helps tailor breathing support.
How similar studies have gone: Observational and pilot studies suggest lung ultrasound is promising in neonates, but few randomized trials have been completed to confirm benefit and safety.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Joan Kirner Women's and Children's, Sunshine Hospital, Western Health
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Arun Sett, PhD
- Email: Arun.Sett@wh.org.au
- Phone: +61405491595
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
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This will try to see if measuring work of breathing with soft chest and abdominal bands can predict which intubated premature infants (≤32 weeks) will tolerate removal of their breathing tube.
-
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This trial will test whether using dexmedetomidine instead of midazolam helps very preterm infants on invasive mechanical ventilation be extubated sooner.
-
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This study tests whether adjusting gentle breathing pressure (PEEP) guided by electrical impedance tomography (EIT) helps keep the lungs open in babies born before 32 weeks who need CPAP or ventilator support.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.