[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646970":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":24,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"GE Healthcare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm)","ACTIVE_COMPARATOR","Subjects with an upper-arm circumference within 17-19 cm, where both Child Cuff and small adult cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Child Cuff or Small Adult cuff Subjects with upper-arm circumferences in non-overlapping small adult -only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.",[13],"Device: NIBP Measurement",{"label":15,"type":10,"description":16,"interventionNames":17},"Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm)","Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: -Small Adult cuff, or -Adult cuff Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","NIBP Measurement","The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Otto Rahkonen Principal Invastigator","CONTACT","+35894711","otto.rahkonen@hus.fi",[32,48],{"facility":33,"status":34,"city":35,"state":24,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Helsinki University Hospital","RECRUITING","Helsinki","00290","Finland","FI",{"type":40,"coordinates":41},"Point",[42,43],24.93545,60.16952,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":29,"phoneExt":24,"email":30},"Otto Rahkonen Principal Investigator",{"facility":33,"status":34,"city":35,"state":24,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":49,"geoPoint":51,"contacts":52},{"type":40,"coordinates":50},[42,43],{"lat":43,"lon":42},[53],{"name":47,"role":28,"phone":54,"phoneExt":24,"email":30},"+358094711",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100646970","nibp-study-for-neonate-and-pediatric-subject-populations-100646970",false,"NCT07684885","NIBP Study for Neonate and Pediatric Subject Populations","Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations","Inclusion Criteria:\n\n* Age requirement: 0 to \\\u003C 18 years.\n* For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR\n* For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.\n* Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).\n* Have an arterial line as a standard of care, which measures invasive blood pressure.\n* Expected to remain in the unit for the duration of the study procedure.\n\nExclusion Criteria:\n\n* Have previously participated in this study (no subject may participate more than once).\n* Subjects with peripheral arterial diseases (causing left\u002Fright arm difference).\n* Hemodynamically unstable subjects Subjects with complications on vasoactive agents at discretion of the Investigator.\n* Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.\n* Are suffering from infection(s) or immunocompromised subjects that require isolation.\n* For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating.\n* PI, designee or caring physician decision due to subject health conditions","ALL","18 Years",{"count":67,"type":68},110,"ESTIMATED","INTERVENTIONAL",[71],"NA","The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.",[74,75],"Blood Pressure","Blood Pressure Measurement","2026-06-29",{"date":78,"type":79},"2026-07-06","ACTUAL",{"date":81,"type":79},"2025-05-14",{"date":83,"type":68},"2026-12-31",{"name":5,"class":6},2]