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Clinical Trials/NCT07636902
NCT07636902RecruitingNot Applicable

Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico

Istituto Giannina Gaslini1 site in 1 country150 target enrollmentStarted: January 1, 2026Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
— to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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