drugset / Trial / NCT06722118

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

NCT06722118 ↗

Phase 3 Not yet recruiting 348 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-06-15
Primary completion
2028-06
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.25 mg/kg Intravenous

Indications

No indication recorded.