[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07577336":3,"trial-entities:NCT07577336":114,"trial-summary:NCT07577336":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":49,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":80,"locations":82,"central_contacts":100,"overall_officials":108,"references":112,"see_also_links":113},"NCT07577336","STUDY00003934","Portable MRI for Pediatric Hypoxic Ischemic Brain Injury","Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury","RECRUITING","2027-12","2026-07","2026-07-08","2026-07-06","Children's Mercy Hospital Kansas City","OTHER",false,"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.","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.\n\nOur institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:\n\n1. 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.\n2. Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent \"helmet\" to rest the head in during the exam.\n3. Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside.\n4. 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.",[19,20,21,22,23,24],"Acute Brain Injury","Hypoxia, Brain","Ischemia, Brain","Brain Injuries","Trauma, Brain","Stroke",[],"INTERVENTIONAL","DIAGNOSTIC",[29],"NA",{"count":31,"type":32},200,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Portable MRI","Enrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +\u002F- 24 hours of a clinically obtained, conventional MRI and\u002For head CT",[39],"Portable MRI Arm",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Scavenged Sample Collection","Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.",[39],[45],{"measure":46,"description":47,"timeFrame":48},"Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries.","Perform pMRI on pediatric ICU patients within +\u002F- 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",[50,53],{"measure":51,"description":52,"timeFrame":48},"Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries","Perform pMRI on pediatric ICU patients within +\u002F- 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.",{"measure":54,"description":55,"timeFrame":48},"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 +\u002F- 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.","ALL",null,"17 Years",{"inclusion":60,"exclusion":64,"raw_text":79},[61,62,63],"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",[65,66,67,68,69,70,71,72,73,74,75,76,77,78],"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","Inclusion Criteria\n\n* Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit\n* Ages 0-17 years at study enrollment\n* Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI\n\nExclusion Criteria\n\n* Pregnancy\n* Active implants such as\n\n  * Pacemaker\n  * Implanted defibrillator\n  * Implanted insulin pump\n  * Deep brain stimulator\n  * Vagus nerve stimulator\n  * Cochlear implant\n  * Programmable shunt\n* MRI incompatible surgical hardware (e.g., staples, screws, etc.)\n* Metal-containing tattoos or permanent make-up on head or neck\n* Suspected metal in eye, e.g.,\n* Former or current welders, metal workers, or individuals with a metal injury\n* Metal shrapnel",[81],"CHILD",[83],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":97},"Children's Mercy Hospital and Clinics","Kansas City","Missouri","64108","United States",[90,94],{"name":91,"role":92,"email":93},"Maura Sien, RT(R), CCRC","CONTACT","mesien@cmh.edu",{"name":95,"role":92,"email":96},"Jessica Wallisch, MD","jwallisch@cmh.edu",{"lat":98,"lon":99},39.09973,-94.57857,[101,104],{"name":102,"role":92,"phone":103,"email":96},"Jessica S Wallisch, MD","(816) 234-3041",{"name":105,"role":92,"phone":106,"email":107},"Allison Scott, RN, CCRC","(913) 515-7535","abscott@cmh.edu",[109],{"name":102,"affiliation":110,"role":111},"Children's Mercy Kansas City","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Hypoxic Ischemic Encephalopathy",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":129},true,{"design":121,"status":122,"heading":6,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study planning to enroll 200 participants. It will compare the portable MRI to standard imaging methods.","completed","This study is looking at a new way to detect brain injuries in children using a portable MRI (magnetic resonance imaging) machine. This special MRI machine can be brought right to a child's bedside in the intensive care unit (ICU), which is safer and easier than moving very sick children to a standard MRI. The study will compare the images from this portable MRI to images from regular MRIs or CT scans to see how well it finds acute (sudden) brain injuries caused by a lack of oxygen (hypoxic ischemic brain injury). We want to see if this portable MRI can accurately diagnose these injuries in children aged 0-17 years who are in the ICU and suspected of having this type of brain injury. The goal is to understand how this portable MRI can best be used in hospitals for children.","The primary outcome for this study is measured during intensive care admittance, with an average of 1 month.",141,"If you participate, your child will have a portable MRI at their bedside within 24 hours of a standard MRI or head CT. Any leftover blood or spinal fluid samples from routine clinical tests may also be collected.","Not stated in the trial record.",[36],"v2"]