Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06697808

Acronym

CUPID-Peds

Enrollment

169

Registered

2024-11-20

Start date

2024-11-24

Completion date

2027-04-01

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

head injury, imaging, pediatrics

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy of Cranial Point-of-Care Ultrasound	Day 1	The diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) is reported reported by comparing the counts of positive and negative findings for the two imaging modalities with sensitivity, specificity, positive predictive value and negative predictive value.

Countries

United States

Contacts

CONTACTDenise Fraga, MD

Denise.Fraga@advocatehealth.org704-355-3181

PRINCIPAL_INVESTIGATORDenise Fraga, MD

Atrium Health Wake Forest Baptist

Outcome results