Corticosteroids Before Extubation in Pediatric Intensive Care Unit

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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).
• Другое 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).

Первичные конечные точки

• Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO) [Срок оценки: Within 48 hours post-extubation]

Вторичные конечные точки (6)

• Cumulative incidence of reintubation due to RDUAO [Срок оценки: Within 48 hours following a planned extubation]
• Odds ratios associated with the occurrence of RDUAO [Срок оценки: Within 48 hours post-extubation]
• Number of days of hospitalization in pediatric intensive care unit (PICU) [Срок оценки: Up to 28 days]
• Number of ventilator-free days in PICU [Срок оценки: Up to 28 days]
• Number of days with non-invasive ventilation (NIV) post-extubation [Срок оценки: Up to 28 days]
• Incidence of IV-DXM side effects [Срок оценки: Up to 48 hours post-extubation]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06722118 · APHP220674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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