RECRUITING Phase 3 ClinicalTrials.gov

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

Sponsor: Assistance Publique - Hôpitaux de Paris • ClinicalTrials.gov ID: NCT06722118

Registry updated: 2026-08-25

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Description

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.

Interventions

Dexamethasone IV (Drug)
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 (Other)
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).

Eligibility criteria

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

Conditions

Intensive Care Pediatric

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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