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Lung Ultrasound to Reduce the Number of Chest X-rays in Very Preterm Infants in the First 2 Weeks After Birth: A Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Australia
Joan Kirner Women's and Children's, Sunshine Hospital, Western Health
RECRUITING
Melbourne
Contact Information
Primary
Arun Sett, PhD
Arun.Sett@wh.org.au
+61405491595
Backup
Niranjan Abraham, MD
Niranjan.AbrahamWilliam@wh.org.au
0413751479
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 180
Treatments
Experimental: Lung ultrasound group
Infants randomised to this group will have lung ultrasound as their first
Active_comparator: Standard care
Infants in the standard arm will receive chest X-ray as their first form of lung imaging. Lung ultrasound will not be permitted in this group.
Sponsors
Leads: Western Health, Australia

This content was sourced from clinicaltrials.gov