NCT06697808 Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics
| NCT ID | NCT06697808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 169 participants |
| Start Date | 2024-11-24 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 169 participants in total. It began in 2024-11-24 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Denise Fraga, MD
PRINCIPAL INVESTIGATOR
Atrium Health Wake Forest Baptist
Frequently Asked Questions
Who can join the NCT06697808 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06697808 currently recruiting?
Yes, NCT06697808 is actively recruiting participants. Contact the research team at Denise.Fraga@advocatehealth.org for enrollment information.
Where is the NCT06697808 trial being conducted?
This trial is being conducted at Charlotte, United States.
Who is sponsoring the NCT06697808 clinical trial?
NCT06697808 is sponsored by Wake Forest University Health Sciences. The principal investigator is Denise Fraga, MD at Atrium Health Wake Forest Baptist. The trial plans to enroll 169 participants.