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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lung ultrasound group
DeviceInfants 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.
Standard Care
Diagnostic testInfants in the standard group will receive chest X-ray as their first line imaging tool. Lung ultrasound will not be permitted in this group.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Lung ultrasound groupExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The mean difference in number of x-rays and radiation exposure in the intervention group
The total number of chest X-rays performed in the study period
Time frame
Until day 14 of lifeSecondary outcomes
1
The mean difference of X-rays for entire admission (until discharge or death)
Total number of x-rays performed from enrolment in study until death or discharge from hospital
Time frame
From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months2
The mean difference of X-rays and radiation exposure by gestational age at birth
The total number of CXR performed in the study period stratified by gestational groups (\< 28 weeks' gestation and \>/= to 28 weeks' gestation)
Time frame
Until day 14 of life3
Time to administering surfactant if clinically indicated
The mean difference in minutes to administer surfactant if clinically indicted between the lung ultrasound and chest x-ray groups
Time frame
Until day 14 of life4
Proportion of infants in the intervention arm who require CXR as first-line imaging due to lung ultrasound not being available
The number of CXRs performed after a lung ultrasound is performed in the intervention group due to the ultrasound clinicians or system not being available.
Time frame
Until day 14 of lifeOther outcomes
1
Serious adverse event [1]
Oxygen requirement of fraction of inspired oxygen (FiO2) ≥20% of baseline for 2 hours or more after the lung imaging assessment
Time frame
During or within 1 hour after each scheduled lung imaging assessment2
Serious adverse event [2]
Acute oxygen desaturation (peripheral oxygen saturations \[SpO2\] \<90%) that required the lung imaging to be terminated
Time frame
During or within 1 hour after each scheduled lung imaging assessment3
Serious adverse event [3]
Requirement of escalation of respiratory support
Time frame
During or within 1 hour after each scheduled lung imaging assessment4
Serious adverse event [4]
Apnoea requiring stimulation or other intervention that required the lung imaging to be terminated
Time frame
During or within 1 hour after each scheduled lung imaging assessmentSponsors and contacts
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Source ClinicalTrials.gov