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NCT Number: NCT07577336

Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Jessica Wallisch, MD

CONTACT

[email protected]

Maura Sien, RT(R), CCRC

CONTACT

[email protected]

About this study

Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others.

Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:

  • Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside.
  • Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam.
  • Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside.
  • Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Scavenged Sample Collection

Other

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

Primary outcomes

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

    Time frame: During intensive care admittance, an average of 1 month

    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.

Secondary outcomes

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

    Time frame: During intensive care admittance, an average of 1 month

    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.

  2. 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.

    Time frame: During intensive care admittance, an average of 1 month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Scott, RN, CCRC

CONTACT

[email protected]

(913) 515-7535

Jessica S Wallisch, MD

CONTACT

[email protected]

(816) 234-3041

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury

Acronym: pMRI for pHIBI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 11, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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