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Trauma, BrainNCT05726201

(POCUS) As an Early Screening Tool for Diagnosing Skull Fractures in Children

An observational study of Trauma, Brain, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the accuracy of POCUS as a screening tool for early diagnosis of skull fractures in children with mild closed head injuries admitted to the emergency department. Read more about this study

Who is it for?
Ages 2 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Trauma, Brain
What is being tested?
ultrasound
How many people
95 participants
Where
1 siteEgypt
Study dates
23 Jul 2023to 30 Jan 2026
How long will I take part?
2 Days
Phase
Observational
Are there results?
None posted in the registry

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 2 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: * Age group 2 - 18 years old * Both genders * Blunt head trauma within 24hours of admission to the ED. * Glasgow Coma Scale scores of 10 to 15. * Localizing evidence of scalp trauma (cephalohematoma, focal pain, deformity)

Who may be able to join

  • Age group 2 - 18 years old
  • Both genders
  • Blunt head trauma within 24hours of admission to the ED.
  • Glasgow Coma Scale scores of 10 to 15.
  • Localizing evidence of scalp trauma (cephalohematoma, focal pain, deformity)

Who cannot join

  • Patients who are less than 2 years old or more than 18 years old
  • Patients with open head wounds
  • Ventricular shunts
  • Bleeding disorders
  • Known brain tumors
  • Pre-existing neurological disorders complicating assessment

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Omar Ibrahim Abdelsalam

    Asyut, Asyut Governorate, 71515

Other trials in Egypt

About this study

Official title: Point-Of-Care Ultrasound (POCUS) As an Early Screening Tool for Diagnosing Skull Fractures In Children With Mild Closed Head Injuries

This study aims to evaluate the accuracy of POCUS as a screening tool for early diagnosis of skull fractures in children with mild closed head injuries admitted to the emergency department. The results would aid the emergency physicians to speed up the management and reduce the cost of diagnosing skull fractures and TBI.

Read the detailed description

Trauma is defined as a physical injury from an external source. Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age groups.Head trauma can result in skull fractures which are a common cause of morbidity and mortality in children. There is a high flow of presentations in the Pediatric Emergency Department (PED) and primary care. Children are more susceptible to head trauma and skull fractures than adults. The child's head size is approximately 18% of the total body surface area in infancy. Compared to an adult skull, the child's skull is thinner and more pliable, thus providing less protection to the brain. The Centers for Disease Control and Prevention in the USA reported 749,000 ED visits for injury to the head in children under the age of 15 years old in 2016. One Up to 8% of children aged 3-17.

The Causes of head injury and skull fractures can be classified into accidental and non accidental injuries. Commonly, head injuries are caused by a fall. Other causes can include motor vehicle accidents (MVA), sports-related injuries, or other direct blows to the head. Occasionally, depressed "ping-pong" fractures can occur in newborns due to injury at birth. Fortunately, the majority (80% to 90%) of head injuries can be classified as mild. Very few injuries are life-threatening or require neurosurgical intervention. The incidence of skull fractures in children following head injury ranges from 2% to 20%, and further epidemiological studies are needed for more accurate incidence and prevalence rates.

Skull fractures are more common in children under the age of 2 years following head trauma. A fracture of the calvarium (skull cap) is more common than one at the base of the skull. Skull fractures can cause many complications, such as skin damage, soft tissue injuries, bone fractures, and brain tissue injuries, which are known as traumatic brain injuries. Traumatic brain injury (TBI), which is defined as a disruption in the normal brain's function, can involve both adults and children, but its pathophysiology and management are different in children.

When the skull is fractured, the dura mater is prone to damage. The dural laceration is common in Diastatic skull fractures and should be diagnosed because of its complications.

Head CT scan, an X-ray-based modality, is widely used to diagnose skull fractures and TBI. Children are more sensitive to ionizing radiation, and the relative risk of cancer is higher in them. Identification of skull fractures in children is clinically relevant because these fractures may need surgical intervention irrespective of the presence of TBI. Skull fractures could be associated with non-accidental trauma, and physicians should always consider this potential association .In addition, skull fractures may need follow-up because linear fractures may predispose children to uncommon but serious complications such as expanding fractures or leptomeningeal cysts. Clinicians must weigh the risk of missing a clinically important skull fracture and potentially associated TBI and the risks associated with performing a CT (i.e., carcinogenic effect, and changes in the cognitive function afterwards).

Given the dangers of using X-rays and computed tomography (CT) scans, physicians are attempting to reduce the use of these methods as much as possible. Solutions include the development of clinical guidelines to reduce unnecessary exposure (e.g, PECARN Rule) or alternative imaging methods such as magnetic resonance imaging (MRI) or ultrasonography (US). US is a noninvasive tool that is superior to CT and MRI for detecting dura's status. Also, it is preferred over MRI as being more available in the emergency department.Rabiner et al. stated the following benefits of point-of-care ultrasound (POCUS): (a) early diagnosis of a patient and early consultation; (b) reduction in CT scan request; (c) as a diagnostic tool when there is no access to CT scan; and (d) a triage tool in a disaster area with difficult conditions.Weinberg et al. reported that the accuracy of POCUS was higher in diagnosing longitudinal bone fractures, especially in young adults and children. Recent studies reported high sensitivity and specificity of POCUS in the clinical diagnosis of skull fractures (91%,96% respectively ). It is noticeable that POCUS may be a tool for detecting skull fractures; it does not rule out brain lesions which might be more hazardous for the injured patients, and in high-risk patients, a CT scan should be performed. Although POCUS is considered a good diagnostic tool, extensive use of ultrasound to diagnose skull fractures has significant limitations. Firstly, the location of the injury has to be clearly identified; the skin mustn't have any damage. In many cases, finding the injury location is challenging. Second, is the need for sedation in children to perform this procedure. The need for relaxation and immobility is always one of the challenges of performing ultrasound in children.

The algorithm of the PECARN rule is widely used to decide on performing CT scans in childrenwith mild head trauma . In this algorithm, the use of CT for children with a moderate risk for brain injury has always been challenged, especially when the child visits an ED center where there is no CT scan, and the physician wants to refer the child to a higher-levelcenter for CT. In this case, if the child is eligible for ultrasound, the location of the injury is clear, and the skin is not torn, ultrasound can be used to determine the existence of a skull fracture which would be an indication to perform CT to discard intracranial injuries A recent meta-analysis recommended the consideration of POCUS in patients that meet no other major or multiple minor criteria for a CT scan than a clinically suspected skull fracture, or when a skull fracture cannot be excluded; consequently, when no fracture is identified, a CT scan might not be needed. Therefore, using POCUS to rule out a skull fracture could potentially reduce the utilization of CT and unnecessary exposure of children to ionizing radiation. The aim of POCUS is not to detect TBI, but it can identify skull fracture which is an important predictor of Clinically important TBI (ciTBI).Based on these assumptions, the POCUS is better included in the early screening of children with mild closed head injuries rather than to be a definitive diagnostic tool. This study will screen pediatric patients with mild closed head injury aiming to define the role of POCUS in risk stratification for TBI and its applicability in conjunction with the clinical prediction rules. Thereby, the decision to ''recommend CT'' will be based on both early admission POCUS and PECARN rule.

Conditions
Trauma, Brain
Being tested
ultrasound
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasoundDiagnostic test

    Point-Of-Care Ultrasound (POCUS) As an Early Screening Tool for Diagnosing Skull Fractures In Children With Mild Closed Head Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. main

    Evaluate the diagnostic accuracy (sensitivity and specificity) of point of-care ultrasound (POCUS) as a screening tool for identifying and early diagnosis skull fractures in children with mild closed head trauma

    Measured: 3 years

Secondary outcomes (4)
  1. Incidence

    Describing the incidence of skull fracture in children

    Measured: 3 years

  2. PECARN predictive rule

    PECARN predictive rule

    Measured: 3 years

  3. Computed Tomography Scanning skull

    CT skull findings.

    Measured: 3 years

  4. Agreement ratio

    the agreement ratio between the results of the POCUS, PECARN rule and CT findings.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start23 Jul 2023
  3. Primary completion30 Oct 2025
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
95 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726201
Sponsor's protocol ID
POCUS for skull fracture
Status last verified
Jul 2023
First submitted
31 Jan 2023
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma, Brain, run by Assiut University at 1 site in Egypt.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 May 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

main (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 May 2026.

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