Pediatric Skull Fracture Detection with Ultrasound in the Emergency Department
Official title: Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico
Run by Istituto Giannina Gaslini · NCT07636902 · Data updated 2026-11-12
This study tests whether point-of-care skull ultrasound can accurately detect skull fractures in children with minor head injuries compared with CT scans.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 6 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Istituto Giannina Gaslini Academic / other |
| Locations | 1 site (Genova, Italy) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07636902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children 6 years old or younger with blunt head trauma, scalp hematoma, and GCS ≥ 14, who have provided informed consent.
✕Probably not a fit
Children with unstable vital signs or conditions requiring immediate CT or other imaging may not benefit from ultrasound-based assessment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this study, researchers compare musculoskeletal ultrasound performed at the bedside to cranial CT, the current reference standard, for children with minor head trauma and scalp hematomas. The goal is to measure diagnostic performance—sensitivity, specificity, predictive values, and likelihood ratios—for detecting skull fractures. Eligible participants are children aged 6 years or younger with blunt head trauma, a skull hematoma, and a GCS of 14 or higher, enrolled with informed consent. The ultrasound intervention is performed in the pediatric emergency department, and CT serves as the reference test to determine accuracy. Safety considerations include standard ED assessment and exclusion of unstable patients.
Why it matters
Potential benefit: If successful, bedside ultrasound could provide a rapid, radiation-free option to rule in or out skull fractures in young children.
How similar studies have gone: Previous pediatric imaging studies have shown variable ultrasound accuracy; this study builds on growing interest but remains among early efforts in this specific application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6 years of age or less at enrollment * Blunt head trauma with skull haematoma * Glasgow Coma Scale (GCS) \>= 14 * signature of the informed consent form Exclusion Criteria: \- Haemodinamic or neurological instability
Where it's running
-
IRCCS Giannina Gaslini Institute
Genova, Italy, Italy Recruiting
Study contacts
- Study coordinator: Matteo D'Alessandro, MD, PhD
- Email: matteodalessandro@gaslini.org
- Phone: 3498265535
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.