NCT07636902

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Dec 2027

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

May 23, 2026

Last Update Submit

June 5, 2026

Conditions

Skull Fractures

Keywords

skull fracturespoint-of-care ultrasoundpediatric emergency department

Outcome Measures

Primary Outcomes (4)

  • Sensibility

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

    Baseline, prior to Computed Tomography of the head

  • Specificity

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

    Baseline, prior to Computed Tomography scan of the head

  • Positive predictive value

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

    Baseline, prior to Computed Tomography scan of the head

  • Negative predictive value

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

    Baseline, prior to Computed Tomography scan of the head

Study Arms (1)

Patients with minor head trauma associated with scalp hematoma and suspected skull fracture

EXPERIMENTAL
Diagnostic Test: Skull ultrasound

Interventions

Skull ultrasoundDIAGNOSTIC_TEST

Skull point-of-care ultrasound

Patients with minor head trauma associated with scalp hematoma and suspected skull fracture

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age or less at enrollment
  • Blunt head trauma with skull haematoma
  • Glasgow Coma Scale (GCS) \>= 14
  • signature of the informed consent form

You may not qualify if:

  • \- Haemodinamic or neurological instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Giannina Gaslini Institute

Genova, Italy, 16147, Italy

RECRUITING

Related Publications (3)

  • Alexandridis G, Verschuuren EW, Rosendaal AV, Kanhai DA. Evidence base for point-of-care ultrasound (POCUS) for diagnosis of skull fractures in children: a systematic review and meta-analysis. Emerg Med J. 2022 Jan;39(1):30-36. doi: 10.1136/emermed-2020-209887. Epub 2020 Dec 3.

    PMID: 33273039BACKGROUND

  • Choi JY, Lim YS, Jang JH, Park WB, Hyun SY, Cho JS. Accuracy of Bedside Ultrasound for the Diagnosis of Skull Fractures in Children Aged 0 to 4 Years. Pediatr Emerg Care. 2020 May;36(5):e268-e273. doi: 10.1097/PEC.0000000000001485.

    PMID: 29698348BACKGROUND

  • Parri N, Crosby BJ, Glass C, Mannelli F, Sforzi I, Schiavone R, Ban KM. Ability of emergency ultrasonography to detect pediatric skull fractures: a prospective, observational study. J Emerg Med. 2013 Jan;44(1):135-41. doi: 10.1016/j.jemermed.2012.02.038. Epub 2012 May 11.

    PMID: 22579023BACKGROUND

MeSH Terms

Conditions

Skull Fractures

Interventions

Echoencephalography

Condition Hierarchy (Ancestors)

Craniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

NeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Central Study Contacts

Matteo D'Alessandro, MD, PhD

CONTACT

3498265535matteodalessandro@gaslini.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 9, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)