Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

NCT ID: NCT06697808

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-24

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denise Fraga, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

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Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Denise Fraga, MD

Role: CONTACT

704-355-3181

Facility Contacts

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Denise Fraga, MD

Role: primary

704-355-3181

Other Identifiers

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IRB00111568

Identifier Type: -

Identifier Source: org_study_id

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