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Study details
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Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Vanderbilt University Medical Center
NCT IDNCT04801589ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

372

Study length

about 5.4 years

Ages

0.843834922875406–11

Locations

1 site in TN

What this study is about

This trial is testing whether a specific sedation approach, using dexmedetomidine and midazolam, can reduce delirium and improve outcomes for children on ventilators. The goal is to determine the best sedative medication to help these vulnerable patients recover more fully after critical illness.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Dexmedetomidine
  • 2.Take Midazolam

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IV

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

dexmedetomidine, midazolam (Benzodiazepine; short-acting)

Drug routes

injection

Endpoints

Secondary: Functional status, Incidence of post-traumatic stress symptoms in patients and parents/caregivers, Mortality

Body systems

Psychiatry / Mental Health