Using cranial ultrasound to detect brain injuries in children
Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)
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 |
|---|---|
| Enrollment | 169 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT06697808 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients who require a head CT scan due to suspected traumatic brain injury.
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.
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 performed: While the use of ultrasound for intracranial pathology detection is innovative, similar studies have shown promise in improving diagnostic accuracy in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlotte, North Carolina
- 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@atriumhealth.org
- Phone: 704-355-3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.