Minimizing radiation exposure in very preterm babies
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
This trial will try using bedside lung ultrasound instead of routine chest X-rays to guide breathing support for babies born before 32 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | N/A to 24 Hours |
| Sex | All |
| Sponsor | Western Health, Australia Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06975189 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial compares care guided by lung ultrasound with standard care that relies on chest X-rays in very preterm infants. Eligible infants (22 to 31+6 weeks' gestation) admitted to the NICU who require lung imaging will be enrolled with parental consent and allocated to either the lung ultrasound group or standard care. Lung ultrasound is radiation-free and can be performed at the bedside to provide more frequent, real-time information about lung status. The study will measure radiation exposure and short-term respiratory management outcomes while monitoring safety and tolerability.
Who should consider this trial
Good fit: Infants born between 22 and 31+6 weeks' gestation who are admitted to the NICU, require lung imaging for respiratory reasons, and have a parent or guardian able to give informed consent are ideal candidates.
Not a fit: Babies who only need chest X-rays for non-respiratory reasons (such as device placement or cardiac assessment), or those whose skin or clinical stability prevents ultrasound, are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, this approach could substantially reduce radiation exposure and provide faster, bedside lung monitoring that helps tailor breathing support.
How similar studies have performed: Observational and pilot studies suggest lung ultrasound is promising in neonates, but few randomized trials have been completed to confirm benefit and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria * 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.
Where this trial is running
Melbourne, Victoria
- Joan Kirner Women's and Children's, Sunshine Hospital, Western Health — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Arun Sett, PhD
- Email: Arun.Sett@wh.org.au
- Phone: +61405491595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.