[{"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":11,"responsibleParty":72,"collaborators":11,"id":74,"slug":11,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":96,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":11},{"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",{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":85,"type":86},348,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92],"Intensive Care Pediatric",[94,95],"Corticosteroids","Intensive Care Pediatrics","NOT_YET_RECRUITING","2025-04-25",{"date":99,"type":100},"2025-04-27","ACTUAL",{"date":102,"type":86},"2025-06-15",{"date":104,"type":86},"2028-07",{"name":5,"class":6}]