Using cranial ultrasound to detect brain injuries in children
Official title: Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)
Run by Wake Forest University Health Sciences · NCT06697808 · Data updated 2026-11-12
This study is testing if a special type of ultrasound can help doctors find serious brain injuries in children with head trauma without using radiation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 169 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Charlotte, North Carolina) |
| Status | Recruiting |
| Started | November 24, 2024 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT06697808 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients who require a head CT scan due to suspected traumatic brain injury.
✕Probably not a fit
Patients with open skull fractures, previous hemicraniectomy, existing surgical defects in the skull, or those transitioning to comfort care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of B-mode cranial point-of-care ultrasound (cPOCUS) as a non-invasive and cost-effective method for detecting significant intracranial pathology in pediatric patients with blunt head trauma. By improving the selection process for head CT scans, the study seeks to enhance diagnostic accuracy and reduce unnecessary radiation exposure. The research is particularly focused on children in resource-limited settings, where timely and accurate imaging can significantly impact treatment outcomes and reduce long-term neurological complications.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more accurate diagnosis of traumatic brain injuries in children, ultimately improving patient outcomes.
How similar studies have gone: While the use of ultrasound for intracranial pathology detection is innovative, similar studies have shown promise in improving diagnostic accuracy in pediatric populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring a head computed tomography (CT) or brain MRI 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
Where it's running
-
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Denise Fraga, MD — Atrium Health Wake Forest Baptist
- Study coordinator: Denise Fraga, MD
- Email: Denise.Fraga@advocatehealth.org
- Phone: 704-355-3181
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.