MINImising Total Radiation EXposure in Preterm Infants

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorWestern Health, Australia

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lung ultrasound group
  • Standard Care

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators