Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07772323
Status
Not Yet Recruiting

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Conditions

  • Acute Brain Injury
  • Brain Neoplasm
  • Hydrocephalus
  • Hypoxia-Ischemia, Brain
  • Intracranial Hemorrhage
  • Stroke
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Study Details

Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the developing brain to ionizing radiation. A safe, portable, radiation-free bedside tool is needed to help decide which children need a head CT, to speed CT when injury is present, and to safely monitor injured children between scans. This study evaluates B-mode cranial point-of-care ultrasound (cPOCUS) performed through the temporal (and frontal) bone windows in children undergoing a clinically indicated head CT in the pediatric emergency department (ED) and pediatric intensive care unit (PICU). Children's thin skulls provide adequate acoustic windows in more than 95% of cases. cPOCUS is acquired by trained research scanners within 6 hours of head CT and interpreted offline by two blinded expert readers; the radiology CT report is the diagnostic gold standard. This is a prospective observational study; cPOCUS results are not returned to the clinical team in real time and do not change clinical care.

Key Dates

First listed
Aug 19, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: Children undergoing clinically indicated head CT for suspected ABI in the pediatric ED and PICU
    Combined ED + PICU sampling enriches for CT-positive cases and supplies the serial-imaging subset.

Primary Outcome Measure

Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT [ Time Frame: First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Aarti Sarwal, MD
[email protected]
804-828-9499
Alia Marie O'Meara, MD
[email protected]
804-828-9499

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