[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448582":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":348,"collaborators":351,"id":357,"slug":358,"hasResults":359,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":359,"sex":365,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":41,"studyType":371,"phases":372,"briefSummary":374,"conditions":375,"keywords":377,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","This arm will be exposed to the study intervention: a standardized seizure protocol.",[13],"Drug: Standardized seizure protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm",[19],"Drug: Conventional seizure protocol",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Standardized seizure protocol","The intervention is a standardized seizure protocol for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).",[9],[27],"midazolam",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Conventional seizure protocol","The control is the EMS agency's current seizure protocol, based on conventional calculation-based dosing. These vary from one EMS agency to the other with respect to recommended midazolam doses ranging from 0.05-0.3 mg\u002Fkg and with multiple route choices listed, including intravenous, intraosseous, intramuscular, intranasal, and rectal.\n\nfor paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).",[15],[27],[34],{"name":35,"affiliation":5,"role":36},"Manish I Shah, MD, MS","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","650-723-3319",null,"mshah5@stanford.edu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Leonard Basobas, MS","773-504-5963","lbasobas@stanford.edu",[48,67,82,96,110,125,140,155,170,185,200,215,230,244,259,274,289,303,318,333],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Arizona","RECRUITING","Tucson","Arizona","85724","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-110.92648,32.22174,{"lat":60,"lon":59},[63],{"name":64,"role":39,"phone":65,"phoneExt":41,"email":66},"Joshua B Gaither, MD","520-626-1670","jgaither@aemrc.arizona.edu",{"facility":68,"status":50,"city":69,"state":70,"zip":71,"country":54,"countryCode":55,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Children's Hospital of Los Angeles","Los Angeles","California","90027",{"type":57,"coordinates":73},[74,75],-118.24368,34.05223,{"lat":75,"lon":74},[78],{"name":79,"role":39,"phone":80,"phoneExt":41,"email":81},"Todd P Chang, MD, MAcM","323-361-2109","tochang@chla.usc.edu",{"facility":83,"status":50,"city":84,"state":70,"zip":85,"country":54,"countryCode":55,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of California, Davis","Sacramento","95817",{"type":57,"coordinates":87},[88,89],-121.4944,38.58157,{"lat":89,"lon":88},[92],{"name":93,"role":39,"phone":94,"phoneExt":41,"email":95},"Daniel Nishijima, MD, MAS","916-734-3884","dnishijima@ucdavis.edu",{"facility":97,"status":50,"city":98,"state":70,"zip":99,"country":54,"countryCode":55,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"University of California, San Francisco","San Francisco","94143",{"type":57,"coordinates":101},[102,103],-122.41942,37.77493,{"lat":103,"lon":102},[106],{"name":107,"role":39,"phone":108,"phoneExt":41,"email":109},"Nicolaus Glomb, MD, MPH","415-476-3345","nicolaus.glomb@ucsf.edu",{"facility":111,"status":50,"city":112,"state":113,"zip":114,"country":54,"countryCode":55,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of Colorado","Aurora","Colorado","80045",{"type":57,"coordinates":116},[117,118],-104.83192,39.72943,{"lat":118,"lon":117},[121],{"name":122,"role":39,"phone":123,"phoneExt":41,"email":124},"Kathleen Adelgais, MD, MPH","303-724-2595","kathleen.adelgais@childrenscolorado.org",{"facility":126,"status":50,"city":127,"state":128,"zip":129,"country":54,"countryCode":55,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"type":57,"coordinates":131},[132,133],-77.03637,38.89511,{"lat":133,"lon":132},[136],{"name":137,"role":39,"phone":138,"phoneExt":41,"email":139},"Kathleen Brown, MD","202-476-4177","kbrown@childrensnational.org",{"facility":141,"status":50,"city":142,"state":143,"zip":144,"country":54,"countryCode":55,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Emory University","Atlanta","Georgia","30322",{"type":57,"coordinates":146},[147,148],-84.38798,33.749,{"lat":148,"lon":147},[151],{"name":152,"role":39,"phone":153,"phoneExt":41,"email":154},"Claudia R Morris, MD","404-727-5500","claudia.r.morris@emory.edu",{"facility":156,"status":50,"city":157,"state":158,"zip":159,"country":54,"countryCode":55,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Indiana University","Indianapolis","Indiana","46202",{"type":57,"coordinates":161},[162,163],-86.15804,39.76838,{"lat":163,"lon":162},[166],{"name":167,"role":39,"phone":168,"phoneExt":41,"email":169},"Gregory W Faris, MD","317-962-3886","gfaris@iu.edu",{"facility":171,"status":50,"city":172,"state":173,"zip":174,"country":54,"countryCode":55,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"University of Michigan","Ann Arbor","Michigan","48105",{"type":57,"coordinates":176},[177,178],-83.74088,42.27756,{"lat":178,"lon":177},[181],{"name":182,"role":39,"phone":183,"phoneExt":41,"email":184},"Stacey Noel, MD","734-763-7488","sknoel@med.umich.edu",{"facility":186,"status":50,"city":187,"state":188,"zip":189,"country":54,"countryCode":55,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University at Buffalo","Buffalo","New York","14203",{"type":57,"coordinates":191},[192,193],-78.87837,42.88645,{"lat":193,"lon":192},[196],{"name":197,"role":39,"phone":198,"phoneExt":41,"email":199},"Brian Clemency, MD","716-645-9726","bc34@buffalo.edu",{"facility":201,"status":50,"city":202,"state":203,"zip":204,"country":54,"countryCode":55,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Mecklenburg EMS","Charlotte","North Carolina","28226",{"type":57,"coordinates":206},[207,208],-80.84313,35.22709,{"lat":208,"lon":207},[211],{"name":212,"role":39,"phone":213,"phoneExt":41,"email":214},"Douglas Swanson, MD","704-355-2000","dswanson@medic911.com",{"facility":216,"status":50,"city":217,"state":218,"zip":219,"country":54,"countryCode":55,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":57,"coordinates":221},[222,223],-84.51439,39.12711,{"lat":223,"lon":222},[226],{"name":227,"role":39,"phone":228,"phoneExt":41,"email":229},"Lauren Riney, DO","513-803-2969","lauren.riney@cchmc.org",{"facility":231,"status":50,"city":232,"state":218,"zip":233,"country":54,"countryCode":55,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Nationwide Children's Hospital","Columbus","43205",{"type":57,"coordinates":235},[236,237],-82.99879,39.96118,{"lat":237,"lon":236},[240],{"name":241,"role":39,"phone":242,"phoneExt":41,"email":243},"Julie Leonard, MD, MPH","614-722-4384","julie.leonard@nationwidechildrens.org",{"facility":245,"status":50,"city":246,"state":247,"zip":248,"country":54,"countryCode":55,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Oregon Health and Sciences University","Portland","Oregon","97239",{"type":57,"coordinates":250},[251,252],-122.67621,45.52345,{"lat":252,"lon":251},[255],{"name":256,"role":39,"phone":257,"phoneExt":41,"email":258},"Matthew Hansen, MD, MCR","503-494-7551","hansemat@ohsu.edu",{"facility":260,"status":50,"city":261,"state":262,"zip":263,"country":54,"countryCode":55,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"University of Pittsburgh","Pittsburgh","Pennsylvania","15224",{"type":57,"coordinates":265},[266,267],-79.99589,40.44062,{"lat":267,"lon":266},[270],{"name":271,"role":39,"phone":272,"phoneExt":41,"email":273},"Sylvia Owusu-Ansah, MD, MPH","412-692-7692","sylvia.owusuansah@chp.edu",{"facility":275,"status":50,"city":276,"state":277,"zip":278,"country":54,"countryCode":55,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"University of Texas Southwestern","Dallas","Texas","75235",{"type":57,"coordinates":280},[281,282],-96.80667,32.78306,{"lat":282,"lon":281},[285],{"name":286,"role":39,"phone":287,"phoneExt":41,"email":288},"Geoffrey Lowe, MD","214-456-1359","geoffrey.lowe@utsouthwestern.edu",{"facility":290,"status":50,"city":291,"state":277,"zip":292,"country":54,"countryCode":55,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"Baylor College of Medicine","Houston","77030",{"type":57,"coordinates":294},[295,296],-95.36327,29.76328,{"lat":296,"lon":295},[299],{"name":300,"role":39,"phone":301,"phoneExt":41,"email":302},"Kathryn M Kothari, MD","832-824-5497","kathryn.kothari@bcm.edu",{"facility":304,"status":50,"city":305,"state":306,"zip":307,"country":54,"countryCode":55,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"University of Utah","Salt Lake City","Utah","84108",{"type":57,"coordinates":309},[310,311],-111.89105,40.76078,{"lat":311,"lon":310},[314],{"name":315,"role":39,"phone":316,"phoneExt":41,"email":317},"Maija Holsti, MD, MPH","801-587-7450","maija.holsti@hsc.utah.edu",{"facility":319,"status":50,"city":320,"state":321,"zip":322,"country":54,"countryCode":55,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"University of Washington","Seattle","Washington","98104",{"type":57,"coordinates":324},[325,326],-122.33207,47.60621,{"lat":326,"lon":325},[329],{"name":330,"role":39,"phone":331,"phoneExt":41,"email":332},"Andrew Latimer, MD","206-521-1588","alatim@uw.edu",{"facility":334,"status":50,"city":335,"state":336,"zip":337,"country":54,"countryCode":55,"cosmosGeoPoint":338,"geoPoint":342,"contacts":343},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":57,"coordinates":339},[340,341],-87.90647,43.0389,{"lat":341,"lon":340},[344],{"name":345,"role":39,"phone":346,"phoneExt":41,"email":347},"Lorin Browne, DO","414-266-2625","lbrowne@mcw.edu",{"type":36,"investigatorFullName":349,"investigatorTitle":350,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Manish Shah","Professor",[352,355,356],{"name":353,"class":354},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":304,"class":6},{"name":290,"class":6},"100448582","phase-3-pediatric-dose-optimization-for-seizures-in-emergency-medical-services-100448582",false,"NCT05121324","Pediatric Dose Optimization for Seizures in Emergency Medical Services","Pediatric Dose Optimization for Seizures in EMS (PediDOSE)","PediDOSE","Inclusion Criteria:\n\n* Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND\n* Under the care of a paramedic; AND\n* Transported by an EMS agency participating in the study\n\nExclusion Criteria:\n\n* A prior history of a benzodiazepine allergy; OR\n* Known or presumed pregnancy; OR\n* Severe growth restriction based on the paramedic's subjective assessment","ALL","6 Months","13 Years",{"count":369,"type":370},6700,"ESTIMATED","INTERVENTIONAL",[373],"PHASE3","The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children.\n\nPediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner.\n\nOne aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice.\n\nAnother aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings.\n\nIf this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.",[376],"Seizures",[378,379],"Child","Emergency Medical Services","2025-09-26",{"date":382,"type":383},"2025-09-30","ACTUAL",{"date":385,"type":383},"2022-08-08",{"date":387,"type":370},"2026-09-30",{"name":5,"class":6},20]