Not Yet RecruitingPhase 3

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

348 participantsStarted 2025-06-15

Plain-language 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.

Who can participate

Age range

2 Days – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Within 48 hours post-extubation

Trial details

NCT IDNCT06722118

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Stéphane Dauger, MD PhD

140032187 stephane.dauger@aphp.fr

View on ClinicalTrials.gov More Intensive Care Pediatric trials