Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location status: Recruiting

Location contact

Denise Fraga, MD

CONTACT

[email protected]

704-355-3181

About this study

B-mode cranial point-of-care ultrasound (cPOCUS) being used in this study is an innovative, low-risk, inexpensive solution for diagnosing clinically significant intracranial pathology in children presenting with blunt head trauma which could be valuable for resource- austere environments. Traumatic brain injury remains a leading cause of death and disability in children. In addition, those who present with suspected acute brain injury in resource-austere environments may be at high risk of long-term neurologic sequelae or death. Early neuroimaging to identify traumatic brain injury and guide interventions is key to preventing their neurologic morbidity and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients requiring a head computed tomography (CT) as the standard of care
Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at Atrium Health Wake Forest Brenner Children's Hospital or Levine Children's Hospital

Exclusion criteria

Patients with open skull fractures
Previous hemicraniectomy
Existing surgical defect in the skull
Patients being transitioned to comfort care

Treatment and study plan

Primary outcomes

Diagnostic Accuracy of Cranial Point-of-Care Ultrasound

Time frame: Day 1

The diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) is reported reported by comparing the counts of positive and negative findings for the two imaging modalities with sensitivity, specificity, positive predictive value and negative predictive value.

Study contacts

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

Denise Fraga, MD

CONTACT

[email protected]

704-355-3181

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)

Acronym: CUPID-Peds

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Nov 20, 2024
Registry last updated: Aug 28, 2025

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.

Published trials that share one or more normalized conditions with this study.

Recruiting