Corticosteroids Before Extubation in Critically Ill Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter, double‑blind study will compare intravenous dexamethasone given before extubation to placebo in children aged 2 days to 6 years who have been on mechanical ventilation for at least 36 hours. The goal is to see if pre‑extubation steroids reduce the incidence of respiratory distress due to upper airway obstruction after extubation. Participating centers include hospitals in Bordeaux, Lyon, and Garches. Key eligibility includes stable oxygenation, PEEP, and airway/cardiovascular status, with parental consent required. Outcomes will inform pediatric extubation practices in PICUs where steroid use is not yet standard.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Stéphane Dauger, MD PhD
• Email: stephane.dauger@aphp.fr
• Phone: 140032187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.