Portable MRI for Pediatric Hypoxic Ischemic Brain Injury
Trial statusRecruiting
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 volunteersQualifiers
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
Any patient who has a contraindication to having an MRI
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
Trial design
Design model
Single group
Treatments tested in this trial
Portable MRI
DeviceEnrolled 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 interventionRemaining 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 groupGroup 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 month2
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 month3
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 monthSecondary outcomes
1
Assess the association of imaging findings and rates of clinical neurologic events
The rate of seizures, pupillary changes, focal neurologic deficits, and other clinical neuromonitoring data will be assessed for correlation to and type of acute brain injury diagnosed on neuroimaging.
Time frame
From ICU admission until final neuroimaging during active study participationSponsors and contacts
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Source ClinicalTrials.gov