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NCT Number: NCT06722118

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

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.

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Key information

Age range

2 day–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone IV

Drug

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).

Placebo

Other

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 outcomes

  1. Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)

    Time frame: Within 48 hours post-extubation

Secondary outcomes

  1. Cumulative incidence of reintubation due to RDUAO

    Time frame: Within 48 hours following a planned extubation

  2. Odds ratios associated with the occurrence of RDUAO

    Time frame: Within 48 hours post-extubation

  3. Number of days of hospitalization in pediatric intensive care unit (PICU)

    Time frame: Up to 28 days

  4. Number of ventilator-free days in PICU

    Time frame: Up to 28 days

  5. Number of days with non-invasive ventilation (NIV) post-extubation

    Time frame: Up to 28 days

  6. Incidence of IV-DXM side effects

    Time frame: Up to 48 hours post-extubation

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Stéphane Dauger, MD PhD

CONTACT

[email protected]

140032187 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: COBEX-PED

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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