Skull FracturesSPEED-UPNCT07636902
Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol
A study testing Skull ultrasound in people with Skull Fractures, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Skull Fractures
- What is being tested?
- Skull ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Haemodinamic or neurological instability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Giannina Gaslini Institute
Genova, Italy, 16147
Matteo D'Alessandro, 3498265535 ext. +39, matteodalessandro@gaslini.org
matteo.dalessandro87@gmail.com
About this study
Official title: Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico
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
- Being tested
- Skull ultrasound
- Keywords
- skull fractures, point-of-care ultrasound, pediatric emergency department
- Medical subject headings
- Skull Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skull ultrasoundDiagnostic test
Skull point-of-care ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Patients with minor head trauma associated with scalp hematoma and suspected skull fracture | Experimental | Not described Receives: Diagnostic Test: Skull ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility
Sensibility of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)
Measured: Baseline, prior to Computed Tomography of the head
Specificity
Specificity of ultrasound examination regarding fracture diagnosis, compared to gold standard (Computed Tomography scan)
Measured: 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)
Measured: 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)
Measured: Baseline, prior to Computed Tomography scan of the head
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skull FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636902
- Sponsor's protocol ID
- CET LIGURIA 389-2025 ID14871
- Acronym
- SPEED-UP
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33273039Choi 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.
PubMed 29698348Parri 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.
PubMed 22579023
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico
- ClinicalTrials.gov ID
- NCT07636902
- Acronym / sponsor ID
- SPEED-UP / CET LIGURIA 389-2025 ID14871
- Conditions
- Skull Fractures
- Keywords
- skull fractures, point-of-care ultrasound, pediatric emergency department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with minor head trauma associated with scalp hematoma and suspected skull fracture | Experimental | Diagnostic Test: Skull ultrasound |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Haemodinamic or neurological instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skull ultrasoundSkull point-of-care ultrasound | Diagnostic test | Patients with minor head trauma associated with scalp hematoma and suspected skull fracture |
Primary outcome
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 33273039Alexandridis 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.
- Background: PubMed 29698348Choi 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.
- Background: PubMed 22579023Parri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skull ultrasound in people with Skull Fractures, run by Istituto Giannina Gaslini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo D'Alessandro, MD, PhD (3498265535 ext. +39, matteodalessandro@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility (time frame: Baseline, prior to Computed Tomography of the head). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636902, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.