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Clinical Trials in France / NCT06722118
Recruiting Phase 3

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

NCT06722118 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 3
Started
2025-10-28
Last updated
2026-08-25

Condition(s) studied

Intensive Care Pediatric

Investigational drug(s) / intervention(s)

Dexamethasone IV →Placebo

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).

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).

Study 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.

Eligibility

Sex
ALL
Min age
2 Days
Max age
6 Years
Healthy volunteers
No
Inclusion Criteria: * Patients intubated with an endotracheal tube with or without a cuff, * Aged from 2 days post-term to 6 years, * On mechanical ventilation for at least 36 hours, And meeting the following extubation criteria: * Extubation planned by the medical team * Fraction of inspired oxygen (FiO2) ≤ 45%, * Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology, * Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O, * Peak inspiratory pressure ≤ 22 cmH2O or presence of cough. * Affiliated with a social security system, * Collection of informed consent from the parental authority, by both parents or the legal guardian(s). Exclusion Criteria: * Refusal of consent by at least one parent or by the legal guardian(s), * Patient with a contraindication to IV-DXM: * Uncontrolled local or general infection, * Active viral infections (hepatitis, herpes, chickenpox, shingles), * Live vaccines, * Severe coagulation disorders, * Ongoing gastrointestinal bleeding, * Known hypersensitivity to IV-DXM or one of its excipients. * Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable, * Patient receiving State Medical Aid, * Patient on long-term NIV, * Known upper airway pathology (UAP) before intubation or at the time of extubation, * History of UAP surgery within the month preceding inclusion, * Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician, * Decision to limit or stop therapeutic interventions. * Premature patients aged less than 40 weeks of gestation * Newborns aged less than 2 days after post-term birth

Primary outcome measure(s)

  • Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO) — Within 48 hours post-extubation

Trial sites (15)

FacilityCityRegionStatus
CHU Bordeaux - GH Pellegrin Bordeaux France Recruiting
HFME Lyon-Bron Bron France Recruiting
Hôpital Raymond Poincaré AP-HP Garches France Recruiting
Hôpital Bicêtre AP-HP Le Kremlin-Bicêtre France Recruiting
CHU Lille Lille France Recruiting
La Timone AP-HM Marseille France Recruiting
CHRU Nancy Nancy France Recruiting
Hôpital Necker AP-HP Paris France Recruiting
Hôpital Necker Paris France Recruiting
Hôpital Necker Paris France Recruiting
Hôpital Robert Debré AP-HP Paris France Recruiting
Hôpital Trousseau AP-HP Paris France Recruiting
Hôpital Haut-Lévêque CHU Bordeaux Pessac France Recruiting
CHU Strasbourg Hautepierre Strasbourg France Recruiting
CHRU de Tours - Hôpital Clocheville Tours France Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06722118 on ClinicalTrials.gov ↗ ← All trials in France