Clinical trial NCT06722118: Corticosteroids Before Extubation in Pediatric Intensive Care Unit
Official title: Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Intensive Care Pediatric
Keywords: Corticosteroids
Intensive Care Pediatrics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 348
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, placebo-controlled study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)
timeFrame: Within 48 hours post-extubation
Secondary outcomes:
measure: Cumulative incidence of reintubation due to RDUAO
timeFrame: Within 48 hours following a planned extubation
measure: Odds ratios associated with the occurrence of RDUAO
timeFrame: Within 48 hours post-extubation
measure: Number of days of hospitalization in pediatric intensive care unit (PICU)
timeFrame: Up to 28 days
measure: Number of ventilator-free days in PICU
timeFrame: Up to 28 days
measure: Number of days with non-invasive ventilation (NIV) post-extubation
timeFrame: Up to 28 days
measure: Incidence of IV-DXM side effects
timeFrame: Up to 48 hours post-extubation
Other outcomes:
Locations:
Study officials:
References: