[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571581":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":11,"studyPopulation":11,"armGroups":41,"interventions":52,"overallOfficials":11,"centralContacts":61,"locations":72,"responsibleParty":258,"collaborators":11,"id":260,"slug":261,"hasResults":262,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":262,"sex":268,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":11,"studyType":274,"phases":275,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)",null,"Within 48 hours post-extubation",[14,17,19,22,24,26],{"measure":15,"description":11,"timeFrame":16},"Cumulative incidence of reintubation due to RDUAO","Within 48 hours following a planned extubation",{"measure":18,"description":11,"timeFrame":12},"Odds ratios associated with the occurrence of RDUAO",{"measure":20,"description":11,"timeFrame":21},"Number of days of hospitalization in pediatric intensive care unit (PICU)","Up to 28 days",{"measure":23,"description":11,"timeFrame":21},"Number of ventilator-free days in PICU",{"measure":25,"description":11,"timeFrame":21},"Number of days with non-invasive ventilation (NIV) post-extubation",{"measure":27,"description":11,"timeFrame":28},"Incidence of IV-DXM side effects","Up to 48 hours post-extubation",{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"RANDOMIZED","PARALLEL","Prospective, randomized, double-blind, placebo-controlled study","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[42,47],{"label":43,"type":44,"description":11,"interventionNames":45},"Intravenous dexamethasone","EXPERIMENTAL",[46],"Drug: Dexamethasone IV",{"label":48,"type":49,"description":11,"interventionNames":50},"Placebo","PLACEBO_COMPARATOR",[51],"Other: Placebo",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"DRUG","Dexamethasone IV","IV-DXM 4mg\u002Fml, injectable solution. Dosage of 0.25 mg\u002Fkg (maximum 5 mg per dose), prepared in a syringe of 5 to 10 ml and administered intravenously to the patient over 10 minutes every 6 hours. The treatment duration ranges from 6 hours (minimum of two doses: H0, H6) to 18 hours (maximum of four doses: H0, H6, H12, H18).",[43],{"type":6,"name":48,"description":59,"armGroupLabels":60,"otherNames":11},"Placebo: 0.9% NaCl solution, prepared in a syringe of 5 to 10 ml and administered intravenously to the patient over 10 minutes every 6 hours. The treatment duration ranges from 6 hours (minimum of two doses: H0, H6) to 18 hours (maximum of four doses: H0, H6, H12, H18).",[48],[62,68],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Stéphane Dauger, MD PhD","CONTACT","140032187","+33","stephane.dauger@aphp.fr",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},"Jérôme Lambert, MD PhD","142499742","jerome.lambert@u-paris.fr",[73,90,103,116,129,142,155,168,181,191,200,209,219,232,245],{"facility":74,"status":75,"city":76,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"CHU Bordeaux - GH Pellegrin","RECRUITING","Bordeaux","France","FR",{"type":80,"coordinates":81},"Point",[82,83],-0.58046,44.84124,{"lat":83,"lon":82},[86],{"name":87,"role":64,"phone":88,"phoneExt":66,"email":89},"Anouk Navion","0557821853","anouk.navion@chu-bordeaux.fr",{"facility":91,"status":75,"city":92,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"HFME Lyon-Bron","Bron",{"type":80,"coordinates":94},[95,96],4.91303,45.73865,{"lat":96,"lon":95},[99],{"name":100,"role":64,"phone":101,"phoneExt":66,"email":102},"Fleur Cour Andlauer","0472129736","fleur.cour-andlauer@chu-lyon.fr",{"facility":104,"status":75,"city":105,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Hôpital Raymond Poincaré AP-HP","Garches",{"type":80,"coordinates":107},[108,109],2.18232,48.84226,{"lat":109,"lon":108},[112],{"name":113,"role":64,"phone":114,"phoneExt":66,"email":115},"Aben Essid","0147104615","aben.essid@aphp.fr",{"facility":117,"status":75,"city":118,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Hôpital Bicêtre AP-HP","Le Kremlin-Bicêtre",{"type":80,"coordinates":120},[121,122],2.36073,48.81471,{"lat":122,"lon":121},[125],{"name":126,"role":64,"phone":127,"phoneExt":66,"email":128},"Luc Morin","0145213205","luc.morin@aphp.fr",{"facility":130,"status":75,"city":131,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"CHU Lille","Lille",{"type":80,"coordinates":133},[134,135],3.05512,50.63391,{"lat":135,"lon":134},[138],{"name":139,"role":64,"phone":140,"phoneExt":66,"email":141},"Sylvain Blanadier","0320445962","sylvain.blanadier@chu-lille.fr",{"facility":143,"status":75,"city":144,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"La Timone AP-HM","Marseille",{"type":80,"coordinates":146},[147,148],5.38107,43.29695,{"lat":148,"lon":147},[151],{"name":152,"role":64,"phone":153,"phoneExt":66,"email":154},"Fabrice Michel","0413429353","fabrice.michel@ap-hm.fr",{"facility":156,"status":75,"city":157,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"CHRU Nancy","Nancy",{"type":80,"coordinates":159},[160,161],6.18496,48.68439,{"lat":161,"lon":160},[164],{"name":165,"role":64,"phone":166,"phoneExt":66,"email":167},"Nathan Giroux","0383154648","n.giroux@chru-nancy.fr",{"facility":169,"status":75,"city":170,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Hôpital Necker AP-HP","Paris",{"type":80,"coordinates":172},[173,174],2.3488,48.85341,{"lat":174,"lon":173},[177],{"name":178,"role":64,"phone":179,"phoneExt":66,"email":180},"Vanessa Lopez","01 71 19 61 61","vanessa.lopez@aphp.fr",{"facility":182,"status":75,"city":170,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":183,"geoPoint":185,"contacts":186},"Hôpital Necker",{"type":80,"coordinates":184},[173,174],{"lat":174,"lon":173},[187],{"name":188,"role":64,"phone":189,"phoneExt":66,"email":190},"Mehdi Oualha","01 44 49 42 19","mehdi.oualha@aphp.fr",{"facility":182,"status":75,"city":170,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":192,"geoPoint":194,"contacts":195},{"type":80,"coordinates":193},[173,174],{"lat":174,"lon":173},[196],{"name":197,"role":64,"phone":198,"phoneExt":66,"email":199},"Gilles Orliaguet","0144494458","gilles.orliaguet@aphp.fr",{"facility":201,"status":75,"city":170,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":202,"geoPoint":204,"contacts":205},"Hôpital Robert Debré AP-HP",{"type":80,"coordinates":203},[173,174],{"lat":174,"lon":173},[206],{"name":207,"role":64,"phone":208,"phoneExt":66,"email":67},"Stéphane Dauger","0140034098",{"facility":210,"status":75,"city":170,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"Hôpital Trousseau AP-HP",{"type":80,"coordinates":212},[173,174],{"lat":174,"lon":173},[215],{"name":216,"role":64,"phone":217,"phoneExt":66,"email":218},"Jérôme Rambaud","0171738527","jerome.trousseau@aphp.fr",{"facility":220,"status":75,"city":221,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Hôpital Haut-Lévêque CHU Bordeaux","Pessac",{"type":80,"coordinates":223},[224,225],-0.6324,44.80565,{"lat":225,"lon":224},[228],{"name":229,"role":64,"phone":230,"phoneExt":66,"email":231},"Julien Gotchac","0557656828","Julien.gotchac@chu-bordeaux.fr",{"facility":233,"status":75,"city":234,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"CHU Strasbourg Hautepierre","Strasbourg",{"type":80,"coordinates":236},[237,238],7.74553,48.58392,{"lat":238,"lon":237},[241],{"name":242,"role":64,"phone":243,"phoneExt":66,"email":244},"Françoise Zitvogel","0388128323","francoise.zitvogel@chru-strasbourg.fr",{"facility":246,"status":75,"city":247,"state":11,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"CHRU de Tours - Hôpital Clocheville","Tours",{"type":80,"coordinates":249},[250,251],0.70398,47.39484,{"lat":251,"lon":250},[254],{"name":255,"role":64,"phone":256,"phoneExt":66,"email":257},"Julie Chantreuil","0247474756","J.CHANTREUIL@chu-tours.fr",{"type":259,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100571581","phase-3-corticosteroids-before-extubation-in-pediatric-intensive-care-unit-100571581",false,"NCT06722118","Corticosteroids Before Extubation in Pediatric Intensive Care Unit","Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo","COBEX-PED","Inclusion Criteria:\n\n* Patients intubated with an endotracheal tube with or without a cuff,\n* Aged from 2 days post-term to 6 years,\n* On mechanical ventilation for at least 36 hours,\n\nAnd meeting the following extubation criteria:\n\n* Extubation planned by the medical team\n* Fraction of inspired oxygen (FiO2) ≤ 45%,\n* Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology,\n* Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,\n* Peak inspiratory pressure ≤ 22 cmH2O or presence of cough.\n* Affiliated with a social security system,\n* Collection of informed consent from the parental authority, by both parents or the legal guardian(s).\n\nExclusion Criteria:\n\n* Refusal of consent by at least one parent or by the legal guardian(s),\n* Patient with a contraindication to IV-DXM:\n\n  * Uncontrolled local or general infection,\n  * Active viral infections (hepatitis, herpes, chickenpox, shingles),\n  * Live vaccines,\n  * Severe coagulation disorders,\n  * Ongoing gastrointestinal bleeding,\n  * Known hypersensitivity to IV-DXM or one of its excipients.\n* Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable,\n* Patient receiving State Medical Aid,\n* Patient on long-term NIV,\n* Known upper airway pathology (UAP) before intubation or at the time of extubation,\n* History of UAP surgery within the month preceding inclusion,\n* Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician,\n* Decision to limit or stop therapeutic interventions.\n* Premature patients aged less than 40 weeks of gestation\n* Newborns aged less than 2 days after post-term birth","ALL","2 Days","6 Years",{"count":272,"type":273},348,"ESTIMATED","INTERVENTIONAL",[276],"PHASE3","Fifty to 60% of children admitted to a pediatric intensive care unit (PICU) are placed under invasive mechanical ventilation (MV) at least once during their stay. After extubation, about 30% of these patients will experience respiratory distress due to upper airway obstruction (RDUAO), and about one-third of these cases will require re-intubation. Treating this RDUAO extends the length of stay in the PICU.\n\nPre-extubation corticosteroid therapy has been validated in adults as a preventive treatment for the occurrence of RDUAO. However, the lack of robust data in pediatrics has not allowed for a consensus on the benefit of its use in children on MV in the PICU.\n\nThe investigators propose to conduct a randomized, multicenter, double-blind, placebo-controlled study evaluating the effect of intravenous dexamethasone (IV-DXM) before extubation on the incidence of RDUAO in children.",[279],"Intensive Care Pediatric",[281,282],"Corticosteroids","Intensive Care Pediatrics","2026-08-24",{"date":285,"type":286},"2026-08-25","ACTUAL",{"date":288,"type":286},"2025-10-28",{"date":290,"type":273},"2028-11",{"name":5,"class":6},15]