NCT07772323Not yet recruiting
Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury
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)
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Stroke, Childhood cancers
- NCT number
- NCT07772323
What you commit to
- Study type: Observational
- Planned participants: 220
- From 30 Nov 2026 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior hemicraniectomy
- Cranial surgical defect at the insonation site
Other illness
- Any clinical condition in which cranial ultrasound would delay a time-critical intervention
Other
- Open skull fracture
- Anticipated transition to comfort-only care
Who the study is looking for
- 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)
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.