RecruitingPhase 2NCT06975189

MINImising Total Radiation EXposure in Preterm Infants

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

Sponsor

Western Health, Australia

Enrollment

180 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

neonatal respiratory distress syndrome Preterm neonate

Summary

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.

Eligibility

Max Age: 24 Hours

Inclusion Criteria4

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 Criteria6

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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Interventions

DEVICELung ultrasound group

Infants in the intervention arm will receive lung ultrasound as their first line imaging. Clinicians will be permitted to order a chest x-ray if they require further information or if the lung ultrasound findings are inconclusive or not consistent with the clinical findings.

DIAGNOSTIC_TESTStandard Care

Infants in the standard group will receive chest X-ray as their first line imaging tool. Lung ultrasound will not be permitted in this group.