[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578448":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":44,"collaborators":48,"id":50,"slug":26,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumbar Puncture Comfort Seat Arm","EXPERIMENTAL","This is the group that will have the lumbar puncture conducted in an upright sitting position assisted by the medical device",[13],"Device: A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Arm","ACTIVE_COMPARATOR","This is the group that will have the lumbar puncture conducted in an upright sitting position assisted by the human assistant which is present standard of care",[19],"Other: Standard of Care (SOC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","A novel device for immobilization of babies undergoing upright LP, the present working name (non-proprietary) for the device is LP Comfort Seat (LPCS)","The participant will be placed in the LPCS for their lumbar puncture procedure",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard of Care (SOC)","The patient will be held in the upright position by a human assistant",[15],[32],{"name":33,"affiliation":5,"role":34},"Joel B Cox, Medical Doctor","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Joel B Cox, Principle Investigator and Sponsor, Doctor of Medicine","CONTACT","+19029664400","Joel.Cox@gatewaypaeds.ca",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Amanda Latham, N\u002FA","admin@gatewaypaeds.ca",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Joel Cox","Dr. Joel Cox, MD, FRCPC",[49],{"name":5,"class":6},"100578448",false,"NCT06811428","Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial","NeoCALM","Inclusion Criteria:\n\n* Late preterm (34 + weeks) Gestational Age to Term (42+ weeks GA)\n* Weight of 2.5 - 5 kg\n\nExclusion Criteria:\n\n* Any contraindication to having a lumbar punture procedure","ALL","0 Days","28 Days",{"count":60,"type":61},68,"ESTIMATED","INTERVENTIONAL",[64],"NA","A research trial which compares standard of care against employing a novel device for immobilization of babies undergoing upright LP, the present working name for the device is LP Comfort Seat (LPCS).\n\nThe research question is:\n\nP: In late-preterm to term babies who are 0-28 days and undergoing LP for R\u002FO Sepsis I: Is the LPCS more effective C: Than human\u002FRN assisted upright positioning O: In generating a higher rate of first attempt LP success\n\nPrimary outcome measure is first attempt LP success (any evidence of CSF which is diagnostically useful by content and volume)\n\nSecondary outcome measures could include\n\n1. A qualitatively unadulterated tap (no blood) although as you know this is hard to control even with perfect positioning and technique and single pass\n2. A difference in FLACC score as measure of overall pain\u002Fcomfort between test and control",[67,68],"Sepsis","Meningitis",[70,71,72,73,74,68,67],"Lumbar puncture","Seating device","Positioning device","Newborn","Neonatal","NOT_YET_RECRUITING","2025-01-31",{"date":78,"type":79},"2025-02-06","ACTUAL",{"date":81,"type":61},"2025-03-01",{"date":83,"type":61},"2026-04-01",{"name":46,"class":6}]