Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Brain Injury | — | UNRESOLVED | — |
| Brain Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Hydrocephalus | — | UNRESOLVED | — |
| Hypoxia-Ischemia, Brain | — | UNRESOLVED | — |
| Intracranial Hemorrhage | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Children undergoing clinically indicated head CT for suspected ABI in the pediatric ED and PICU
- description
- Combined ED + PICU sampling enriches for CT-positive cases and supplies the serial-imaging subset.
Primary outcomes (1)
- measure
- Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT
- timeFrame
- First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1)
- description
- Diagnostic accuracy of the adjudicated consensus cPOCUS read (index test) for a binary abnormal versus normal head CT (reference standard = attending radiology CT report), reported as sensitivity, specificity, positive predictive value, and negative predictive value, each with 95% confidence intervals, at the first paired CT-cPOCUS assessment. Abnormal scan is defined as presence of any new midline shift, hydrocephalus or parenchymal echogenicity.
Secondary outcomes (8)
- measure
- Inter-reader reliability of cPOCUS interpretation
- timeFrame
- First paired assessment; monitored quarterly through study completion (up to 24 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available