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Not yet recruiting NCT06722118

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

Phase III Interventional Intensive Care Pediatric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone IV, Placebo.
Who it may be relevant to
Registry conditions: Intensive Care Pediatric. Basic parameters: 2 Days — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo

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.

Interventions

  • Drug Dexamethasone 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).
  • Other Placebo
    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).

Primary outcome measures

  • Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO) [Time frame: Within 48 hours post-extubation]
Secondary outcome measures (6)
  • Cumulative incidence of reintubation due to RDUAO [Time frame: Within 48 hours following a planned extubation]
  • Odds ratios associated with the occurrence of RDUAO [Time frame: Within 48 hours post-extubation]
  • Number of days of hospitalization in pediatric intensive care unit (PICU) [Time frame: Up to 28 days]
  • Number of ventilator-free days in PICU [Time frame: Up to 28 days]
  • Number of days with non-invasive ventilation (NIV) post-extubation [Time frame: Up to 28 days]
  • Incidence of IV-DXM side effects [Time frame: Up to 48 hours post-extubation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06722118 · APHP220674

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗