Intensive Care Pediatric
Conditions
Keywords
Corticosteroids, Intensive Care Pediatrics
Brief 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.
Interventions
DRUGDexamethasone 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).
OTHERPlacebo
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).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, randomized, double-blind, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
2 Days to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO) | Within 48 hours post-extubation |
Secondary
| Measure | 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 |
| 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 |
Countries
France
Contacts
CONTACTStéphane Dauger, MD PhD
CONTACTJérôme Lambert, MD PhD
Outcome results
None listed