Acute Brain InjuryCUPID-PedsNCT07772323
Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury
An observational study of Acute Brain Injury and Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Acute Brain Injury, Traumatic Brain Injury, Intracranial Hemorrhage
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Nov 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Aarti Sarwal, MD, 804-828-9499, aarti.sarwal@vcuhealth.org
Alia Marie O'Meara, MD, 804-828-9499, aarti.sarwal@vcuhealth.org
About this study
Official title: 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)
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.
Read the detailed description
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.
- Conditions
- Acute Brain Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Hydrocephalus, Stroke, Brain Neoplasm
- Keywords
- cranial ultrasound, point-of-care ultrasound, cPOCUS, transcranial B-mode ultrasound, pediatric neuroimaging, head CT, midline shift, diagnostic accuracy, radiation reduction, neurocritical care
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Intracranial Hemorrhages, Hydrocephalus, Stroke, Brain Neoplasms, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing clinically indicated head CT for suspected ABI in the pediatric ED and PICU | Combined ED + PICU sampling enriches for CT-positive cases and supplies the serial-imaging subset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Serial paired scans over ICU stay (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- UMass Chan Medical School, Atrium Health Levine Children's Hospital, Children's Hospital of Richmond at VCU
- Responsible party
- Sponsor
- Investigators
- Aarti Sarwal, MD, Principal investigator, Virginia Commonwealth UniversityAlia Marie O'Meara, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772323
- Sponsor's protocol ID
- HM300000147
- Acronym
- CUPID-Peds
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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