Portable MRI for Pediatric Hypoxic Ischemic Brain Injury
NCT07577336 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-05-11
Summary
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.
Conditions
- Acute Brain Injury
- Hypoxia, Brain
- Ischemia, Brain
- Brain Injuries
- Trauma, Brain
- Stroke
Interventions
- DEVICE
-
Portable MRI
Enrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +/- 24 hours of a clinically obtained, conventional MRI and/or head CT
- OTHER
-
Scavenged Sample Collection
Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.
Sponsors & Collaborators
-
Children's Mercy Hospital Kansas City
lead OTHER
Principal Investigators
-
Jessica S Wallisch, MD · Children's Mercy Kansas City
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
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