Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol

Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07636902

Acronym

SPEED-UP

Enrollment

150

Registered

2026-06-09

Start date

2026-01-01

Completion date

2027-12-31

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skull Fractures

Keywords

skull fractures, point-of-care ultrasound, pediatric emergency department

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.

Interventions

DIAGNOSTIC_TESTSkull ultrasound

Skull point-of-care ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Sensibility	Baseline, prior to Computed Tomography of the head	Sensibility of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)
Specificity	Baseline, prior to Computed Tomography scan of the head	Specificity of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)
Positive predictive value	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)
Negative predictive value	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)

Countries

Italy

Contacts

CONTACTMatteo D'Alessandro, MD, PhD

matteodalessandro@gaslini.org3498265535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026