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NCT07772323
Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury
Conditions: Acute Brain Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Hydrocephalus, Stroke, Brain Neoplasm, Hypoxia-Ischemia, Brain
Sex: All
Ages: 2 Years – 17 Years
Healthy volunteers: No
Enrollment: 220
Sponsor: Virginia Commonwealth University
Location: Virginia Commonwealth University Richmond Virginia
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.
Eligibility Criteria
Inclusion Criteria:
* Children 2 to 17 years of age
* Undergoing a clinically indicated (standard-of-care) head CT for suspected acute brain injury (including trauma, headache with neurologic findings, altered mental status, focal deficit, seizure, post-cardiac-arrest, oncologic neurologic emergency, or intracranial infection)
* Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU (CHoR-VCU)
* Consent obtainable from a legally authorized representative (LAR)
* Cranial ultrasound feasible within the protocol time window (within 6 hours of head CT)
Exclusion Criteria:
* Open skull fracture
* Prior hemicraniectomy
* Cranial surgical defect at the insonation site
* Anticipated transition to comfort-only care
* Any clinical condition in which cranial ultrasound would delay a time-critical intervention
Source: ClinicalTrials.gov (NCT07772323). StuddyBuddy aggregates publicly available trial information.