[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634692":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":140,"collaborators":142,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":26,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":180,"whyStopped":26,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"dexmedetomidine","EXPERIMENTAL","Participants with invasive ventilation will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"midazolam","ACTIVE_COMPARATOR","In the control group, participants will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours",[19],"Drug: Midazolam",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Midazolam","participant will receive midazolam as the comparator group",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Julie Chantreuil, Dr","CONTACT","+33247478214","j.chantreuil@chu-tours.fr",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Lea Savary, Dr","+33147474756","l.savary@chu-tours.fr",[42,59,73,87,101,115,129],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CHU d'Angers","Angers","49933","France","FR",{"type":49,"coordinates":50},"Point",[51,52],-0.55202,47.47156,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":57,"phoneExt":26,"email":58},"Amandine Prenant, Dr","+33241355088","amandine.prenant@chu-angers.fr",{"facility":60,"status":26,"city":61,"state":26,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"CHU de Caen","Caen","14033",{"type":49,"coordinates":64},[65,66],-0.35912,49.18585,{"lat":66,"lon":65},[69],{"name":70,"role":34,"phone":71,"phoneExt":26,"email":72},"David Brossier, Dr","+33231063106","brossier-d@chu-caen.fr",{"facility":74,"status":26,"city":75,"state":26,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"CHU de Lille","Lille","59120",{"type":49,"coordinates":78},[79,80],3.05512,50.63391,{"lat":80,"lon":79},[83],{"name":84,"role":34,"phone":85,"phoneExt":26,"email":86},"Stephane Leteurtre, Pr","+33320445982","stephane.LETEURTRE@chu-lille.fr",{"facility":88,"status":26,"city":89,"state":26,"zip":90,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"CHU de Marseille","Marseille","13385",{"type":49,"coordinates":92},[93,94],5.38107,43.29695,{"lat":94,"lon":93},[97],{"name":98,"role":34,"phone":99,"phoneExt":26,"email":100},"Fabrice Michel, Pr","+33413429525","fabrice.michel@ap-hm.fr",{"facility":102,"status":26,"city":103,"state":26,"zip":104,"country":46,"countryCode":47,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"CHU de Nantes","Nantes","44093",{"type":49,"coordinates":106},[107,108],-1.55336,47.21725,{"lat":108,"lon":107},[111],{"name":112,"role":34,"phone":113,"phoneExt":26,"email":114},"Bénédicte Gaillard-Leroux, Dr","+33240083483","benedicte.gaillardleroux@chu-nantes.fr",{"facility":116,"status":26,"city":117,"state":26,"zip":118,"country":46,"countryCode":47,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"CHU de Strasbourg","Strasbourg","67200",{"type":49,"coordinates":120},[121,122],7.74553,48.58392,{"lat":122,"lon":121},[125],{"name":126,"role":34,"phone":127,"phoneExt":26,"email":128},"Charlie Demelo, Dr","+33388127317","charlie.demelo@chru-strasbourg.fr",{"facility":130,"status":26,"city":131,"state":26,"zip":132,"country":46,"countryCode":47,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"CHU de Tours","Tours","37000",{"type":49,"coordinates":134},[135,136],0.70398,47.39484,{"lat":136,"lon":135},[139],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":141,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[143,146,148,150,152,154],{"name":144,"class":145},"University Hospital, Angers","OTHER_GOV",{"name":147,"class":6},"University Hospital, Lille",{"name":149,"class":6},"Nantes University Hospital",{"name":151,"class":6},"University Hospital, Strasbourg, France",{"name":153,"class":6},"University Hospital, Marseille",{"name":155,"class":6},"University Hospital, Caen","100634692","phase-3-impact-on-delirium-of-the-use-of-dexmedetomidine-as-first-line-sedation-in-pediatric-intensive-care-100634692",false,"NCT07542990","Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care","Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care: the PEDIADEX Randomized Controlled Trial","PEDIADEX","Inclusion Criteria:\n\n* Children between 1month to 17 years and 6 months\n* Sedation and analgesia for mechanical ventilation for more than 12 hours\n* Participants covered by or entitled to French social security\n* Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and\u002For able to consent, informed consent from the participant's legal representative(s)\n* Ability for participant to comply with the requirements of the study\n* Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion\n\nExclusion Criteria:\n\n* Patients under guardianship, curatorship or legal protection\n* Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)\n* High-grade heart conduction disorder (Second or third-degree atrioventricular block)\n* Status epilepticus\n* Intracranial hypertension\n* Sedation for more than 6 hours by benzodiazepines at the time of inclusion\n* Need for paralytic medication (neuromuscular blocker) at admission to PICU\n* Following cardiac surgery\n* Palliative care on admission\n* Significant bradycardia\n* Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine\n* Patient already enrolled in the study previously\n* Expected duration of invasive mechanical ventilation inferior to 12 hours\n* Hospitalized in a pediatric intensive care unit without computerized prescription software","ALL","1 Month","18 Years",{"count":168,"type":169},266,"ESTIMATED","INTERVENTIONAL",[172],"PHASE3","The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is :\n\n• Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ? Researchers will compare dexmetomidine to midazolam, to see if the use of dexmedetomidine reduces the prevalence of delirium.\n\nParticipants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.",[175],"Delirium in the Intensive Care Unit",[177,178,9,15,179],"delirium","pediatric","intensive care unit","NOT_YET_RECRUITING","2026-04-17",{"date":183,"type":184},"2026-04-21","ACTUAL",{"date":186,"type":169},"2026-04-15",{"date":188,"type":169},"2029-08-15",{"name":5,"class":6},7]