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Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Enrolling

Conditions

Traumatic Brain Injury

Study type

Observational

Funder types

Other

Identifiers

NCT06697808
IRB00111568

Details and patient eligibility

About

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.

Full description

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.

Enrollment

169 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Denise Fraga, MD

Data sourced from clinicaltrials.gov

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