Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

NCT07577336 | Recruiting FDA Device

• 1 other identifier: STUDY00003934
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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; Stroke

Keywords

pediatric neurocritical care; neuroimaging

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

  Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional head CT obtained for acute neurologic changes. Compare detection rates and severity of cerebral edema and ischemia by pMRI vs head CT to establish sensitivity and specificity.

  During intensive care admittance, an average of 1 month

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

  Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI that demonstrates acute global hypoxic-ischemic brain injury as read by a clinical neuroradiologist. Compare detection rates and severity of acute global hypoxic-ischemic brain injury by pMRI vs conventional MRI to calculate sensitivity and specificity.

  During intensive care admittance, an average of 1 month

Secondary Outcomes (1)

• Assess the association of imaging findings and rates of clinical neurologic events

  From ICU admission until final neuroimaging during active study participation

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
• Any patient who has a contraindication to having an MRI
• Patients with a passive or active implant will:
• First be reviewed on MRISafety.com to determine MR conditionality
• If the device is listed as Conditional or Unsafe for a 1.5T or a 3T, the device will then be reviewed by the MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Hypoxia, Brain; Brain Ischemia; 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) 816-7929; jwallisch@cmh.edu

Hannah Mendenhall, BSN, RN, CPN

CONTACT

816-816-9850; hmendenhall@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: July 6, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)