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Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

ConditionsAcute Brain InjuryHypoxia, BrainIschemia, BrainBrain InjuriesTrauma, BrainStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorChildren's Mercy Hospital Kansas City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Active implants such as

Pacemaker

Implanted defibrillator

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Portable MRI ArmExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

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

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Mercy Hospital Kansas City

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: