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RECRUITING
NCT06722118
PHASE3

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo

Key Details

Gender

All

Age Range

2 Days - 6 Years

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2025-10-28

Completion Date

2028-11

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone IV

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).

OTHER

Placebo

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).

Locations (15)

CHU Bordeaux - GH Pellegrin

Bordeaux, France

HFME Lyon-Bron

Bron, France

Hôpital Raymond Poincaré AP-HP

Garches, France

Hôpital Bicêtre AP-HP

Le Kremlin-Bicêtre, France

CHU Lille

Lille, France

La Timone AP-HM

Marseille, France

CHRU Nancy

Nancy, France

Hôpital Necker AP-HP

Paris, France

Hôpital Necker

Paris, France

Hôpital Necker

Paris, France

Hôpital Robert Debré AP-HP

Paris, France

Hôpital Trousseau AP-HP

Paris, France

Hôpital Haut-Lévêque CHU Bordeaux

Pessac, France

CHU Strasbourg Hautepierre

Strasbourg, France

CHRU de Tours - Hôpital Clocheville

Tours, France