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Could a simple steroid keep kids off ventilators longer?

NCT ID NCT06722118

Prevention Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether giving dexamethasone, a steroid, just before removing a breathing tube can prevent respiratory distress caused by upper airway swelling in children. About 30% of children in pediatric intensive care experience this distress after extubation, and some need to be re-intubated. The study will compare dexamethasone to a placebo in 348 children aged 2 days to 6 years who have been on a ventilator for at least 36 hours. If it works, it could reduce complications and shorten hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexamethasone given intravenously before removal of the breathing tube
What this could lead to
If effective, this could become a standard preventive treatment to reduce airway complications and shorten PICU stays in children.
What could go wrong
The trial is still testing the idea; results may not show a clear benefit, and dexamethasone can have side effects like increased blood sugar or infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 348 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 days to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intensive care pediatric

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU Nancy

    RECRUITING

    Nancy, France

  • CHRU de Tours - Hôpital Clocheville

    RECRUITING

    Tours, France

  • CHU Bordeaux - GH Pellegrin

    RECRUITING

    Bordeaux, France

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU Strasbourg Hautepierre

    RECRUITING

    Strasbourg, France

  • HFME Lyon-Bron

    RECRUITING

    Bron, France

  • Hôpital Bicêtre AP-HP

    RECRUITING

    Le Kremlin-Bicêtre, France

  • Hôpital Haut-Lévêque CHU Bordeaux

    RECRUITING

    Pessac, France

  • Hôpital Necker

    RECRUITING

    Paris, France

  • Hôpital Necker

    RECRUITING

    Paris, France

  • Hôpital Necker AP-HP

    RECRUITING

    Paris, France

  • Hôpital Raymond Poincaré AP-HP

    RECRUITING

    Garches, France

  • Hôpital Robert Debré AP-HP

    RECRUITING

    Paris, France

  • Hôpital Trousseau AP-HP

    RECRUITING

    Paris, France

  • La Timone AP-HM

    RECRUITING

    Marseille, France

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