Corticosteroids Before Extubation in Pediatric Intensive Care Unit
ConditionIntensive Care Pediatric
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-6
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
Qualifiers
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,
Extubation planned by the medical team
Disqualifiers
Refusal of consent by at least one parent or by the legal guardian(s),
Uncontrolled local or general infection,
Active viral infections (hepatitis, herpes, chickenpox, shingles),
Live vaccines,
Trial design
Treatments tested in this trial
- Dexamethasone IV
- Placebo
Treatment groups
348 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov