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

NCT07772323 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • UMass Chan Medical School

    collaborator UNKNOWN

  • Atrium Health Levine Children's Hospital

    collaborator UNKNOWN

  • Children's Hospital of Richmond at VCU

    collaborator UNKNOWN

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Aarti Sarwal, MD · Virginia Commonwealth University

  • Alia Marie O'Meara, MD · Virginia Commonwealth University

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772323 on ClinicalTrials.gov