Clinical Trial

MINImising Total Radiation EXposure in Preterm Infants

Study acronym: MINI T-Rex
Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-15; most recent amendment 2026-04-13.
Status change: Not Yet Recruiting → Recruiting 2026-04-13
Trial Details
NCT Number NCT06975189
Lead Sponsor Western Health, Australia
Conditions Neonatal Respiratory Distress Syndrome, PreTerm Neonate
Enrollment 180 participants
Start Date 2026-04-13
Primary Completion 2029-08-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-16