Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

Last updated: August 27, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Traumatic Brain Injury

Neurologic Disorders

Brain Injury

Treatment

N/A

Clinical Study ID

NCT06697808
IRB00111568
  • Ages < 18
  • All Genders

Study Summary

To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients requiring a head computed tomography (CT) as the standard of care

  • Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit atAtrium Health Wake Forest Brenner Children's Hospital or Levine Children's Hospital

Exclusion

Exclusion Criteria:

  • Patients with open skull fractures

  • Previous hemicraniectomy

  • Existing surgical defect in the skull

  • Patients being transitioned to comfort care

Study Design

Total Participants: 169
Study Start date:
November 24, 2024
Estimated Completion Date:
April 30, 2027

Study Description

B-mode cranial point-of-care ultrasound (cPOCUS) being used in this study is an innovative, low-risk, inexpensive solution for diagnosing clinically significant intracranial pathology in children presenting with blunt head trauma which could be valuable for resource- austere environments. Traumatic brain injury remains a leading cause of death and disability in children. In addition, those who present with suspected acute brain injury in resource-austere environments may be at high risk of long-term neurologic sequelae or death. Early neuroimaging to identify traumatic brain injury and guide interventions is key to preventing their neurologic morbidity and mortality.

Connect with a study center

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Atrium Health Carolinas Medical Center

    Charlotte 4460243, North Carolina 4482348 28203
    United States

    Active - Recruiting

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