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Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

RecruitingNAAges any - 6 YearsAllIstituto Giannina Gaslini
NCT07636902 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Skull ultrasound
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Where

1 site
IRCCS Giannina Gaslini Institute
Genova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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