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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous dexamethasone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO) | Within 48 hours post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of reintubation due to RDUAO | Within 48 hours following a planned extubation | |
| Odds ratios associated with the occurrence of RDUAO | Within 48 hours post-extubation | |
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Inclusion Criteria:
And meeting the following extubation criteria:
Exclusion Criteria:
Refusal of consent by at least one parent or by the legal guardian(s),
Patient with a contraindication to IV-DXM:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Dauger, MD PhD | Contact | 140032187 | +33 | stephane.dauger@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | 142499742 | +33 | jerome.lambert@u-paris.fr |
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Prospective, randomized, double-blind, placebo-controlled study
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|
| 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). |
|
| Number of days of hospitalization in pediatric intensive care unit (PICU) |
| Up to 28 days |
| Number of ventilator-free days in PICU | Up to 28 days |
| Number of days with non-invasive ventilation (NIV) post-extubation | Up to 28 days |
| Incidence of IV-DXM side effects | Up to 48 hours post-extubation |