Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

NCT06697808 | Recruiting

• 1 other identifier: IRB00111568
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

head injury; imaging; pediatrics

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Cranial Point-of-Care Ultrasound

  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.

  Day 1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients in the Emergency Department or Pediatric Intensive Care Unit due blunt head trauma.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Denise Fraga, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Fraga, MD

CONTACT

704-355-3181; denise.fraga@atriumhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 24, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)