Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorIstituto Giannina Gaslini

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Skull ultrasound

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators