[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659657":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":26,"interventions":39,"overallOfficials":13,"centralContacts":48,"locations":55,"responsibleParty":92,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":13,"maxAge":107,"enrollmentInfo":108,"targetDuration":13,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":122,"whyStopped":13,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Cognitive Neurodevelopment","The primary outcome will be cognitive neurodevelopment as measured by the Bayley Scales of Infant Development at 18 months of age. We will compare the mean cognitive score for infants who received thiamine vs. placebo in addition to standard-of-care treatment.","The end-of-study visit will be conducted at 18 months of age for all participants. This will mean that some participants will be assessed nearly 18 months after their infection and others will be assessed ~6 months from their infection.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Thiamine vs. placebo in addition to standard-of-care treatment","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":21},"QUADRUPLE",[22,23,24,25],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Thiamine","EXPERIMENTAL","Participant will receive IV thiamine in addition to standard of care treatment",[32],"Drug: thiamine hydrochloride 100 mg",{"label":34,"type":35,"description":36,"interventionNames":37},"Placebo","PLACEBO_COMPARATOR","Participant will receive placebo (IV saline solution) in addition to standard-of-care treatment.",[38],"Other: Placebo",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"DRUG","thiamine hydrochloride 100 mg","Patients will receive 100mg of IV thiamine in addition to standard-of-care treatment, once a day for three days",[28],{"type":6,"name":34,"description":46,"armGroupLabels":47,"otherNames":13},"Participants will receive placebo in addition to standard-of-care treatment",[34],[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Jessica Ericson, MD","CONTACT","717 531 0003","282277","jericson@pennstatehealth.psu.edu",[56,76],{"facility":57,"status":13,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Boston Children's Hospital","Boston","Massachusetts","02115","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-71.05977,42.35843,{"lat":67,"lon":66},[70,74],{"name":71,"role":51,"phone":72,"phoneExt":13,"email":73},"Sarah U. Morton, MD, PhD","617-355-6000","Sarah.Morton@childrens.harvard.edu",{"name":71,"role":75,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"facility":77,"status":13,"city":78,"state":79,"zip":80,"country":61,"countryCode":62,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Penn State Health Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":64,"coordinates":82},[83,84],-76.65025,40.28592,{"lat":84,"lon":83},[87,91],{"name":88,"role":51,"phone":89,"phoneExt":13,"email":90},"Brennen Harding, MS","717-531-5656","bharding@pennstatehealth.psu.edu",{"name":50,"role":75,"phone":13,"phoneExt":13,"email":13},{"type":75,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Jessica Ericson","Associate Professor, Pediatrics and Infectious Diseases",[96],{"name":97,"class":98},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100659657","phase-2-thiamine-for-recovery-in-vulnerable-early-life-infections-100659657",false,"NCT07868679","THiamine for Recovery In Vulnerable Early-life Infections","THRIVE","Inclusion Criteria:\n\n1. ≤12 months old\n2. Clinical concern for bacteremia or meningitis (fever or hypothermia and lethargy; fever or hypothermia and poor feeding; fever or hypothermia and seizure, bulging fontanelle or nuchal rigidity)\n3. Legal guardian has provided informed consent\n4. No known neurologic or developmental comorbidity (e.g. trisomy 21, congenital structural brain abnormality)\n5. Weight ≥ 2kg\n\nExclusion Criteria:\n\n1. Known neurologic or developmental comorbidity including genetic disorders\n2. Weight \\\u003C 2 kg\n3. Prior episode of bacteremia or meningitis\n4. Already receiving thiamine as standard-of-care","ALL","12 Months",{"count":109,"type":110},240,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia",[116,117],"Meningitis","Bacteremia",[119,120,121],"thiamine","meningitis","bacteremia","NOT_YET_RECRUITING","2026-10-05",{"date":125,"type":126},"2026-10-09","ACTUAL",{"date":128,"type":110},"2026-12-01",{"date":130,"type":110},"2031-11-30",{"name":5,"class":6},2]