Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

Recruiting now · Not applicable

Conditions studied: Skull Fractures

In brief

The aim of this clinical trial is to compare musculoskeletal ultrasound with the reference standard diagnostic test (cranial CT scan) in patients with minor head trauma associated with scalp hematoma and suspected skull fracture. The primary objective is to assess the diagnostic accuracy of point-of-care ultrasound in detecting skull fractures, in terms of sensitivity, specificity, positive and negative predictive values, and likelihood ratios, using cranial CT as the reference standard.

Key facts

Study ID

NCT07636902

Run by

Istituto Giannina Gaslini

People needed

150

Starts

2026-01-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-09

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Haemodinamic or neurological instability

Where it is running

• IRCCS Giannina Gaslini Institute — Genova, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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