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NCT Number: NCT07636902

Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

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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Key information

Conditions

Skull Fractures Craniocerebral Trauma Fractures, Bone Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Giannina Gaslini Institute

Genova, Italy, 16147

Location status: Recruiting

Location contact

Matteo D'Alessandro

CONTACT

[email protected]

3498265535 ext. +39

Matteo D'Alessandro

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skull ultrasound

Diagnostic Test

Skull point-of-care ultrasound

Primary outcomes

  1. Sensibility

    Time frame: Baseline, prior to Computed Tomography of the head

    Sensibility of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)

  2. Specificity

    Time frame: Baseline, prior to Computed Tomography scan of the head

    Specificity of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)

  3. Positive predictive value

    Time frame: Baseline, prior to Computed Tomography scan of the head

    Positive predictive value of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan of the head)

  4. Negative predictive value

    Time frame: Baseline, prior to Computed Tomography scan of the head

    Negative predictive value of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan of the head)

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo D'Alessandro, MD, PhD

CONTACT

[email protected]

3498265535 ext. +39

Sponsors and collaborators

Lead sponsor

Istituto Giannina Gaslini

Other

Registry information

Official study title

Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico

Acronym: SPEED-UP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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