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Sedation Study for Mechanically Ventilated Children

This study is looking at different ways to sedate (calm) children who are on a breathing machine (mechanical ventilation) in the intensive care unit. Many children on breathing machines experience delirium (a state of confusion) and other problems. This study compares two medications: Dexmedetomidine and Midazolam. Researchers want to see if Dexmedetomidine can reduce delirium better than Midazolam. We are looking for children aged 44 weeks (after conception) up to 11 years old who will be admitted to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt and need a breathing machine and sedation. The main goal is to see how many children experience delirium after 14 days. The study aims to enroll 372 patients, but its current status is unclear.

Study design
This is an interventional study comparing two different sedation medications. It plans to enroll 372 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, daily prevalence of delirium, is measured at 14 days.

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NCT04801589

Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Recruiting
PHASE3Ages 44–11InterventionalPrevention
Vanderbilt University Medical Center
~372 participants
Updated 2025-09-29 on ClinicalTrials.gov
What's tested:DexmedetomidineMidazolam

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Daily prevalence of delirium
Measured over 14 days

Conditions

Delirium
Critical Illness
Sedation Complication
Executive Dysfunction
Post Traumatic Stress Disorder

Explore related trials

Critical Illness

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Heidi Smith, MD, MSCI · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Heidi Smith, MD, MSCI
[email protected]
(615) 936-6808
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Eligibility criteria

Inclusion

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.

What this trial measures

  • Daily prevalence of delirium14 days

    The analysis of delirium prevalence will be conducted using a modified Intention-to-Treat (ITT) population, defined as all patients who were randomized and received study drug. The investigators chose a 14 day evaluation period for delirium, because it represents the best balance of gaining valuable clinical information, while maximizing resource utilization, given the average study drug infusion to be 5 days and maximum duration to be 10 days. Thus our follow-up period will cover 9 additional days of delirium monitoring after the study drug is stopped in the majority of our patients.