[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Joel Cox\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"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":19,"type":20},68,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27],"Sepsis","Meningitis",[29,30,31,32,33,27,26],"Lumbar puncture","Seating device","Positioning device","Newborn","Neonatal","NOT_YET_RECRUITING","2025-01-31",{"date":37,"type":38},"2025-02-06","ACTUAL",{"date":40,"type":20},"2025-03-01",{"date":42,"type":20},"2026-04-01",{"name":44,"class":45},"Joel Cox","OTHER",""]