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MINImising Total Radiation EXposure in Preterm Infants

RecruitingPhase 2Ages any - 24 HoursAllWestern Health, Australia
NCT06975189 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 beca

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lung ultrasound group
  • Standard Care
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Where

1 site
Joan Kirner Women's and Children's, Sunshine Hospital, Western Health
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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