An observational study in Acute Brain Injury, Traumatic Brain Injury and Intracranial Hemorrhage, sponsored by Virginia Commonwealth University. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Virginia Commonwealth University · Observational
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.
Prospective observational cohort study of children undergoing clinically indicated head CT for suspected acute brain injury (ABI) in the pediatric ED and PICU at the Children's Hospital of Richmond at Virginia Commonwealth University (CHoR-VCU). Within 6 hours of the head CT, trained research scanners (acquisition-only role) acquire standardized B-mode cranial point-of-care ultrasound (cPOCUS) using 1-3 MHz phased-array probes through bilateral temporal and frontal windows, exporting de-identified 3-5 second cine loops at and around the midbrain plane to an encrypted offline reading workstation. Two pre-specified expert readers interpret the studies independently and offline in Horos, each blinded to the clinical course, the head-CT report, and one another; discordant cases are resolved by joint re-read to a single adjudicated consensus interpretation, which serves as the cPOCUS index test. The attending radiology head-CT report is the diagnostic gold (reference) standard. Because reads are not returned to the clinical team in real time, cPOCUS is not an assigned intervention, and the endpoints are diagnostic test characteristics, there is no change to clinical care.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 220 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Compared within Brain Injuries, Traumatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Children undergoing a clinically indicated head CT for suspected acute brain injury in the pediatric Emergency Department and Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU. Combined ED + PICU sampling enriches the cohort for CT-positive cases and provides the CT-positive subset with serial paired imaging.
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Exclusion Criteria:
Combined ED + PICU sampling enriches for CT-positive cases and supplies the serial-imaging subset.
Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT
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.
Time frame: First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1)
Inter-reader reliability of cPOCUS interpretation
Agreement between the two blinded expert readers on the binary cPOCUS classification of midline shift, hydrocephalus or parenchymal echogenicity, quantified by Cohen's kappa (prespecified threshold kappa \>= 0.8); observed agreement and Gwet's AC1 reported given anticipated low prevalence.
Time frame: First paired assessment; monitored quarterly through study completion (up to 24 months)
Per-reader diagnostic accuracy and paired reader comparison
Each reader's independent binary cPOCUS call scored against head CT for per-reader sensitivity and specificity for midline shift, hydrocephalus or parenchymal echogenicity ; the two readers compared on the same patients by the paired McNemar test.
Time frame: First paired CT-cPOCUS assessment (Day 1)
Etiology- and subgroup-specific diagnostic accuracy (descriptive)
Descriptive, explicitly underpowered estimates of cPOCUS accuracy by prespecified subgroups: age band (2-5, 6-12, 13-17 years), acoustic-window adequacy, mechanism/clinical presentation, and underlying diagnosis; sex-stratified accuracy prespecified per NIH sex-as-a-biological-variable policy.
Time frame: First paired CT-cPOCUS assessment (Day 1)
Age and skull-thickness inflection point (upper age limit of utility)
Identification of the age/skull-thickness threshold above which cranial ultrasound loses screening utility, from age-stratified accuracy and window-adequacy analysis.
Time frame: Through study completion (up to 24 months)
Pediatric cPOCUS atlas feature and artifact agreement
Inter- and intra-observer agreement (Cohen's kappa, age-stratified) on predefined B-mode features and artifacts annotated with a structured ontology, and CT spatial concordance by Horos reformatting/transparency fusion. Atlas and ontology released open access (Zenodo DOI).
Time frame: Through study completion (up to 24 months)
Longitudinal midline-shift agreement (cPOCUS vs CT)
Agreement between interval change in midline shift (mm) on serial cPOCUS and serial head CT in the CT-positive PICU subset, assessed by Bland-Altman analysis with prespecified limits of agreement.
Time frame: Serial paired scans over ICU stay (up to 24 months)
Longitudinal hydrocephalus and new parenchymal echogenicity agreement
Paired concordance between serial cPOCUS and serial head CT for hydrocephalus (present/absent) and new parenchymal echogenicity/new lesion (present/absent), assessed by McNemar's test.
Time frame: Serial paired scans over ICU stay (up to 24 months)
Evolving versus stable pathology (exploratory longitudinal model)
Exploratory modeling of evolving versus stable pathology on the subsequent CT using logistic generalized estimating equations (GEE) with robust standard errors (patient as clustering unit); decision-curve analysis for net clinical benefit.
Time frame: Serial paired scans over ICU stay (up to 24 months)
Plan to share: Yes — De-identified analytic data supporting published results, the standardized age-stratified pediatric cPOCUS atlas, and the machine-readable feature-and-artifact ontology will be shared open access with persistent Zenodo DOIs. Reporting follows STARD 2015
Supporting information: Study protocol, Statistical analysis plan
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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