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New sedative may cut delirium risk in ventilated kids

NCT ID NCT07542990

Symptom relief Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether dexmedetomidine, a sedative, can lower the chance of delirium (sudden confusion) in children who need a breathing machine in the ICU. About 266 children aged 1 month to 17 years will be randomly assigned to receive either dexmedetomidine or the standard drug midazolam. The main goal is to see if fewer children experience delirium with dexmedetomidine.

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 266 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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

1 month to 18 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: * Children between 1month to 17 years and 6 months * Sedation and analgesia for mechanical ventilation for more than 12 hours * Participants covered by or entitled to French social security * Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and/or able to consent, informed consent from the participant's legal representative(s) * Ability for participant to comply with the requirements of the study * Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion Exclusion Criteria: * Patients under guardianship, curatorship or legal protection * Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age) * High-grade heart conduction disorder (Second or third-degree atrioventricular block) * Status epilepticus * Intracranial hypertension * Sedation for more than 6 hours by benzodiazepines at the time of inclusion * Need for paralytic medication (neuromuscular blocker) at admission to PICU * Following cardiac surgery * Palliative care on admission * Significant bradycardia * Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine * Patient already enrolled in the study previously * Expected duration of invasive mechanical ventilation inferior to 12 hours * Hospitalized in a pediatric intensive care unit without computerized prescription software

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Conditions

The condition(s) this trial relates to.

delirium prevention target

As listed by the trial registrant

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

Delirium in the intensive care unit

How to take part

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

  1. The places running it

    7 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

  • CHU d'Angers

    Angers, 49933, France

  • CHU de Caen

    Caen, 14033, France

  • CHU de Lille

    Lille, 59120, France

  • CHU de Marseille

    Marseille, 13385, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Strasbourg

    Strasbourg, 67200, France

  • CHU de Tours

    Tours, 37000, France

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