Overview
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
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
