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Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

NCT07636902 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

  • Skull Fractures

Interventions

DIAGNOSTIC_TEST

Skull ultrasound

Skull point-of-care ultrasound

Sponsors & Collaborators

  • Istituto Giannina Gaslini

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636902 on ClinicalTrials.gov