Actively Recruiting
Lung Ultrasound to Reduce Chest X-rays in Very Preterm Infants During First 2 Weeks After Birth: A Randomised Controlled Trial
Led by Western Health, Australia · Updated on 2026-04-16
180
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether lung ultrasound can reduce the number of chest X-rays and radiation exposure in very preterm babies born before 32 weeks' gestation who need breathing support after birth. The study addresses the urgent need for safer, real-time lung monitoring tools in Neonatal Intensive Care Units, as current chest X-rays are limited due to radiation risks and availability delays. Chronic lung disease is increasing in these fragile infants, making better imaging methods critical for improving care. Babies admitted to the Neonatal Intensive Care Unit will be randomly assigned to one of two groups: one will receive lung ultrasound as the first imaging tool, while the other will receive chest X-rays as usual. Lung ultrasound is a radiation-free, quick, and gentle form of imaging already used for brain and heart scans in preterm babies. In the ultrasound group, chest X-rays may still be ordered if needed for additional information. The study will measure imaging use and safety during the first two weeks after birth. Participants will be closely monitored with assessments including the number of X-rays taken, radiation exposure, timing of lung imaging and treatment initiation, and duration of breathing support. Safety will be tracked by recording adverse events, and the study will also evaluate cost-effectiveness and acceptability of lung ultrasound among healthcare workers. The total study period includes monitoring until hospital discharge or death, with follow-up up to 12 months.
CONDITIONS
Brief Title
MINImising Total Radiation EXposure in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born from 22 to 31 weeks and 6 days gestation
- Infant admitted to Neonatal Intensive Care Unit (NICU)
- Infant requires lung imaging for respiratory reasons
- Parent or guardian can provide informed consent
You will not qualify if you...
- Infant only needs chest X-ray to confirm device positions (e.g., central line, tubes)
- Chest X-ray needed only for non-respiratory reasons (e.g., heart assessment)
- Clinician concerned about infant's stability or ability to tolerate ultrasound
- Infant's skin cannot tolerate ultrasound gel
- Refusal of consent by parent, guardian, or legal representative
- No parent or guardian available to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks after birth
Participants receive lung imaging to guide respiratory support using either lung ultrasound or chest X-ray as the first-line imaging tool during their stay in the Neonatal Intensive Care Unit.
Multiple imaging assessments during the first 14 days after birth
Duration - Up to 12 months
Participants are observed for safety, clinical outcomes, and radiation exposure until discharge or death, with assessments continuing up to 12 months after randomization.
Follow-up assessments until discharge or death
Trial Site Locations
Total: 1 location
1
Joan Kirner Women's and Children's, Sunshine Hospital, Western Health
Melbourne, Victoria, Australia, 3021
Actively Recruiting
Research Team
A
Arun Sett, PhD
N
Niranjan Abraham, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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