Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

NCT07577336 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00003934
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries.

  Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI. Compare detection rates and severity of ischemia and cerebral edema by pMRI vs conventional MRI to determine sensitivity and specificity.

  During intensive care admittance, an average of 1 month

Secondary Outcomes (2)

• Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries

  During intensive care admittance, an average of 1 month

• Establish the sensitivity and specificity of pMRI relative to head CT for detection of cerebral edema and ischemic brain injury in critically ill patients deemed unstable for standard MRI.

  During intensive care admittance, an average of 1 month

Study Arms (1)

Portable MRI Arm

EXPERIMENTAL

All subjects enrolled with be assigned to Arm 1

Device: Portable MRI; Other: Scavenged Sample Collection

Interventions

Portable MRI DEVICE

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

Portable MRI Arm

Scavenged Sample Collection OTHER

Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.

Portable MRI Arm

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
• Ages 0-17 years at study enrollment
• Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI

You may not qualify if:

• Pregnancy
• Active implants such as
• Pacemaker
• Implanted defibrillator
• Implanted insulin pump
• Deep brain stimulator
• Vagus nerve stimulator
• Cochlear implant
• Programmable shunt
• MRI incompatible surgical hardware (e.g., staples, screws, etc.)
• Metal-containing tattoos or permanent make-up on head or neck
• Suspected metal in eye, e.g.,
• Former or current welders, metal workers, or individuals with a metal injury
• Metal shrapnel

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

MeSH Terms

Conditions

Brain Injuries; Hypoxia, Brain; Brain Ischemia; Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jessica S Wallisch, MD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica S Wallisch, MD

CONTACT

(816) 234-3041; jwallisch@cmh.edu

Allison Scott, RN, CCRC

CONTACT

(913) 515-7535; abscott@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The neuroradiologists will be performing blinded assessments of the portable MRI images.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Intensivist

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share