RecruitingNot ApplicableNCT07636902

Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico


Sponsor

Istituto Giannina Gaslini

Enrollment

150 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Max Age: 6 Years

Inclusion Criteria4

  • 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 Criteria1

  • \- Haemodinamic or neurological instability

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Interventions

DIAGNOSTIC_TESTSkull ultrasound

Skull point-of-care ultrasound


Locations(1)

IRCCS Giannina Gaslini Institute

Genova, Italy, Italy

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NCT07636902


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