[{"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:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100578448","neonatal-comfort-seat-allowing-safe-lumbar-puncture-and-minimizing-failure-a-randomized-controlled-trial-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":20,"type":21},68,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28],"Sepsis","Meningitis",[30,31,32,33,34,28,27],"Lumbar puncture","Seating device","Positioning device","Newborn","Neonatal","NOT_YET_RECRUITING","2025-01-31",{"date":38,"type":39},"2025-02-06","ACTUAL",{"date":41,"type":21},"2025-03-01",{"date":43,"type":21},"2026-04-01",{"name":45,"class":46},"Joel Cox","OTHER",""]