MINImising Total Radiation EXposure in Preterm Infants

Recruiting now · Phase 2

Conditions studied: Neonatal Respiratory Distress Syndrome, PreTerm Neonate

In brief

Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive. Despite this significant global impact, neonatal clinicians have few tools available to guide breathing support. Currently, the only lung imaging tool that is routinely used in the Neonatal Intensive Care Unit is a chest X-ray. To reduce radiation exposure, chest X-rays are usually only performed one or two times a day. As chronic lung disease in babies who survive preterm birth is increasing, there is an urgent need to develop new ways to monitor the lungs of these fragile babies. Lung ultrasound is a form of imaging that is fast, gentle and radiation free. However, it has not been routinely adopted into caring for preterm babies in most countries. This is because there are no randomised controlled trials that have demonstrated the benefit and safety of using lung ultrasound as the first-line imaging tool in preterm babies. The investigators will conduct a randomised controlled trial to demonstrate that lung ultrasound is a quick, safe and accurate alternative to chest x-rays in preterm babies.

Key facts

Study ID

NCT06975189

Run by

Western Health, Australia

People needed

180

Starts

2026-04-13

Expected to finish

2029-12-01

Last updated by the study team

2026-04-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Joan Kirner Women's and Children's, Sunshine Hospital, Western Health — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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