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Not Yet Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07772323). StuddyBuddy aggregates publicly available trial information.