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Could a simple sedative choice save Children's brains in the ICU?

NCT ID NCT04801589

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study looks at two different sedative medicines given to children on breathing machines in the ICU. The goal is to see which one causes less confusion (delirium) and helps the brain recover better. About 372 children up to age 11 will take part. The results could change how doctors sedate young patients to improve their long-term thinking and mental health.

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 372 people

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

Started

May 2021

Expected to finish

Sep 2026

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

44 weeks to 11 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 will be eligible for enrollment if they are 1) aged 44 weeks post-menstrual age and up to 11 years, 2) planned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and 3) requiring mechanical ventilation (MV) and sedation. Pre-pubescent children (\<11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction. Exclusion Criteria: Patients will be excluded (i.e., not approached for consent) if any one is present: 1. Receiving continuous sedation for \> 72 hours prior to screening. 2. Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV. 3. Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness. 4. Clinically significant 2nd or 3rd degree heart block or bradycardia \< 60 beats per minute. 5. Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion). 6. Inability to co-enroll with another study. 7. Expected death or care plan for withdrawal of support measures within 24 hours of enrollment. 8. Bilateral vision loss. 9. Deafness that will preclude delirium evaluation. 10. Inability to understand English that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and/or translation services are actively available in that particular language. 11. Documented allergy to either dexmedetomidine or midazolam. 12. Medical requirement of continuous (infusion) neuromuscular blockade administration that is planned ongoing for at least 48 hours at time of screening. 13. Inability to start the informed consent process within the 72 hours from the time that all inclusion criteria were met (possible reasons): 1. Attending physician refusal 2. 72-hour period of eligibility was exceeded before the patient was enrolled 3. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) refusal 4. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) unavailable 5. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) is non-English speaking and available research staff is not proficient and/or translation services are not available in that particular language. 14. Adjusted dosing weight is \> 50 kg at time of screening.

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Conditions

The condition(s) this trial relates to.

Critical Illness delirium post-traumatic stress disorder Psychomotor Agitation

As listed by the trial registrant

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

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.