MINImising Total Radiation EXposure in Preterm Infants

NCT06975189 | Recruiting Phase 2 DMC

• 1 other identifier: 115953
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Respiratory Distress Syndrome; PreTerm Neonate

Keywords

Lung ultrasound; Respiratory Distress Syndrome; Prematurity

Outcome Measures

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

  Until day 14 of life

Secondary Outcomes (5)

• The mean difference of X-rays for entire admission (until discharge or death)

  From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months

• The mean difference of X-rays and radiation exposure by gestational age at birth

  Until day 14 of life

• Time to administering surfactant if clinically indicated

  Until day 14 of life

• Proportion of infants in the intervention arm who require CXR as first-line imaging due to lung ultrasound not being available

  Until day 14 of life

• Cost-effectiveness

  Until day 14 of life

Other Outcomes (26)

• Serious adverse event [1]

  During or within 1 hour after each scheduled lung imaging assessment

• Serious adverse event [2]

  During or within 1 hour after each scheduled lung imaging assessment

• Serious adverse event [3]

  During or within 1 hour after each scheduled lung imaging assessment

Study Arms (2)

Lung ultrasound group

EXPERIMENTAL

Infants randomised to this group will have lung ultrasound as their first

Device: Lung ultrasound group

Standard care

ACTIVE COMPARATOR

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.

Diagnostic Test: Standard Care

Interventions

Lung ultrasound group DEVICE

Infants 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.

Lung ultrasound group

Standard Care DIAGNOSTIC_TEST

Infants in the standard group will receive chest X-ray as their first line imaging tool. Lung ultrasound will not be permitted in this group.

Standard care

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Health, Australia: lead

Study Sites (1)

Joan Kirner Women's and Children's, Sunshine Hospital, Western Health

Melbourne, Victoria, 3021, Australia

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Arun Sett, PhD

CONTACT

+61405491595; Arun.Sett@wh.org.au

Niranjan Abraham, MD

CONTACT

0413751479; Niranjan.AbrahamWilliam@wh.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians and participants will be unblinded to the study intervention. All outcome analysis will be performed blinded to the study intervention.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 16, 2025
• Study Start: April 13, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)