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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
348
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).
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).
CHU Bordeaux - GH Pellegrin
Bordeaux, France
RECRUITINGHFME Lyon-Bron
Bron, France
RECRUITINGHôpital Raymond Poincaré AP-HP
Garches, France
RECRUITINGHôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, France
RECRUITINGCHU Lille
Lille, France
RECRUITINGLa Timone AP-HM
Marseille, France
RECRUITINGCHRU Nancy
Nancy, France
RECRUITINGHôpital Necker AP-HP
Paris, France
RECRUITINGHôpital Necker
Paris, France
RECRUITINGHôpital Necker
Paris, France
RECRUITING...and 5 more locations
Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)
Time frame: Within 48 hours post-extubation
Cumulative incidence of reintubation due to RDUAO
Time frame: Within 48 hours following a planned extubation
Odds ratios associated with the occurrence of RDUAO
Time frame: Within 48 hours post-extubation
Number of days of hospitalization in pediatric intensive care unit (PICU)
Time frame: Up to 28 days
Number of ventilator-free days in PICU
Time frame: Up to 28 days
Number of days with non-invasive ventilation (NIV) post-extubation
Time frame: Up to 28 days
Incidence of IV-DXM side effects
Time frame: Up to 48 hours post-extubation
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