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Corticosteroids Before Extubation in Pediatric Intensive Care Unit

Study acronym: COBEX-PED
StatusRecruiting
PhasePhase 3
Started2025-10-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 2028 → Oct 2028
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Amendment history

2026-08-24
Study Status, Contacts/Locations v2
Recruitment opened
Trial sites expanded: 0 → 15 locations
Primary completion pushed: 2028-06 → 2028-10
Completion pushed: 2028-07 → 2028-11
Start dateestimated 2025-06-15→confirmed 2025-10-28
2025-04-25
Study Identification, Study Status, Study Description v1
Primary completion date2027-12-01→2028-06
Completion date2027-12-01→2028-07
Start date2024-12-01→2025-06-15
Study title-57 characters
Corticosteroids Before Extubation in Pediatric Intensive Care Unit: a Prospective Randomized Double-blind Multicenter Study
2024-12-03
Original filing
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. Pre-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. The 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.
Trial Details
NCT Number NCT06722118
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Intensive Care Pediatric
Enrollment 348 participants
Start Date 2025-10-28
Primary Completion 2028-10 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-25