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NCT Number: NCT07772323

Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury

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.

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Key information

Conditions

Acute Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Ischemia Brain Neoplasm Brain Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Hydrocephalus Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Intracranial Hemorrhage Intracranial Hemorrhages Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT

    Time frame: First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1)

    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

  1. Inter-reader reliability of cPOCUS interpretation

    Time frame: First paired assessment; monitored quarterly through study completion (up to 24 months)

    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.

  2. Per-reader diagnostic accuracy and paired reader comparison

    Time frame: First paired CT-cPOCUS assessment (Day 1)

    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.

  3. Etiology- and subgroup-specific diagnostic accuracy (descriptive)

    Time frame: First paired CT-cPOCUS assessment (Day 1)

    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.

  4. Age and skull-thickness inflection point (upper age limit of utility)

    Time frame: Through study completion (up to 24 months)

    Identification of the age/skull-thickness threshold above which cranial ultrasound loses screening utility, from age-stratified accuracy and window-adequacy analysis.

  5. Pediatric cPOCUS atlas feature and artifact agreement

    Time frame: Through study completion (up to 24 months)

    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).

  6. Longitudinal midline-shift agreement (cPOCUS vs CT)

    Time frame: Serial paired scans over ICU stay (up to 24 months)

    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.

  7. Longitudinal hydrocephalus and new parenchymal echogenicity agreement

    Time frame: Serial paired scans over ICU stay (up to 24 months)

    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.

  8. Evolving versus stable pathology (exploratory longitudinal model)

    Time frame: Serial paired scans over ICU stay (up to 24 months)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aarti Sarwal, MD

CONTACT

[email protected]

804-828-9499

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Atrium Health Levine Children's Hospital
  • Children's Hospital of Richmond at VCU
  • UMass Chan Medical School

Registry information

Official study 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)

Acronym: CUPID-Peds

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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