Actively Recruiting

Phase 2
Age: 0 - 24Hours
All Genders
ID06975189

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

Age: 0 - 24Hours
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

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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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