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NCT07772323

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

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

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.

Official title: Bedside Cranial Point-of-Care Ultrasound (cPOCUS) for Risk-Stratified Imaging in Pediatric Acute Brain Injury: A Prospective Diagnostic-Accuracy and Longitudinal Biomarker Cohort Study (CUPID-Peds)

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2026-11-30

Completion Date

2028-11-30

Last Updated

2026-08-19

Healthy Volunteers

No

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States