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ClinicalTrials.gov ID

NCT06722118

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

348Estimated

Last Update Posted

Aug 25, 2026Actual

Start Date

Oct 28, 2025Actual

Primary Completion Date

Oct 2028Estimated

Completion Date

Nov 2028Estimated

Official Title

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

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.

• Intensive Care Pediatric

• Dexamethasone IV
• Placebo

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

fleur.cour-andlauer@chu-lyon.fr0472129736 ext. +33

sylvain.blanadier@chu-lille.fr0320445962 ext. +33

n.giroux@chru-nancy.fr0383154648 ext. +33

mehdi.oualha@aphp.fr01 44 49 42 19 ext. +33

gilles.orliaguet@aphp.fr0144494458 ext. +33