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Study identifier: NCT04801589 Synced from ClinicalTrials.gov · July 27, 2026
● Recruiting

Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Condition: Delirium · Critical Illness · Sedation Complication  ·  Sponsor: Vanderbilt University Medical Center

PhasePhase 3
Planned participants372
Who can joinAll sexes, 44 Weeks to 11 Years
Healthy volunteersNo

About this study

Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction and independently prolong duration of ventilation and ICU stay, and the available alternative sedation regimen using dexmedetomidine, an alpha-2 agonist, has been shown to be superior to benzodiazepines in adults, and may mechanistically impact outcomes through positive effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium. The mini-MENDS trial will compare dexmedetomidine and midazolam, and determine the best sedative medication to reduce delirium and improve duration of ventilation, and functional, psychiatric, and cognitive recovery in our most vulnerable patients-survivors of pediatric critical illness.

This description comes directly from the study's public registry record.

Talk to the study team

Heidi Smith, MD, MSCI  ·  (615) 936-6808  ·  heidi.smith@vumc.org

Rebecca Abel, MA  ·  (615) 875-3763  ·  rebecca.abel@vumc.org

Always discuss trial participation with your own doctor first.

Locations (1)

Vanderbilt University Medical CenterNashville, Tennessee, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04801589