Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 10:23 PM
Study NCT ID:
NCT06722118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticosteroids Before Extubation in Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, double-blind, placebo-controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 348}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)', 'timeFrame': 'Within 48 hours post-extubation'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of reintubation due to RDUAO', 'timeFrame': 'Within 48 hours following a planned extubation'}, {'measure': 'Odds ratios associated with the occurrence of RDUAO', 'timeFrame': 'Within 48 hours post-extubation'}, {'measure': 'Number of days of hospitalization in pediatric intensive care unit (PICU)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of ventilator-free days in PICU', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of days with non-invasive ventilation (NIV) post-extubation', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of IV-DXM side effects', 'timeFrame': 'Up to 48 hours post-extubation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corticosteroids', 'Intensive Care Pediatrics'], 'conditions': ['Intensive Care Pediatric']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "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"}, 'identificationModule': {'nctId': 'NCT06722118', 'acronym': 'COBEX-PED', 'briefTitle': 'Corticosteroids Before Extubation in Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo', 'orgStudyIdInfo': {'id': 'APHP220674'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous dexamethasone', 'interventionNames': ['Drug: Dexamethasone IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dexamethasone IV', 'type': 'DRUG', 'description': 'IV-DXM 4mg/ml, injectable solution. Dosage of 0.25 mg/kg (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).', 'armGroupLabels': ['Intravenous dexamethasone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stéphane Dauger, MD PhD', 'role': 'CONTACT', 'email': 'stephane.dauger@aphp.fr', 'phone': '140032187', 'phoneExt': '+33'}, {'name': 'Jérôme Lambert, MD PhD', 'role': 'CONTACT', 'email': 'jerome.lambert@u-paris.fr', 'phone': '142499742', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}