Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skull ultrasound.
- Who it may be relevant to
- Registry conditions: Skull Fractures. Basic parameters: up to 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico
Overview
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 test Skull ultrasound
Skull point-of-care ultrasound
Primary outcome measures
- Sensibility [Time frame: Baseline, prior to Computed Tomography of the head]
- Specificity [Time frame: Baseline, prior to Computed Tomography scan of the head]
- Positive predictive value [Time frame: Baseline, prior to Computed Tomography scan of the head]
- Negative predictive value [Time frame: Baseline, prior to Computed Tomography scan of the head]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Giannina Gaslini Institute — Genova
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. PMID 33273039
- 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 29698348
- 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 22579023
Identifiers
NCT: NCT07636902 · CET LIGURIA 389-2025 ID14871