Goal-Directed Sedation in Mechanically Ventilated Infants and Children

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.

NCT Number	NCT04801589
Lead Sponsor	Vanderbilt University Medical Center Collaborators: Pfizer, National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Delirium, Critical Illness, Sedation Complication, Executive Dysfunction, Post Traumatic Stress Disorder
Enrollment	372 participants
Start Date	2021-05-10
Primary Completion	2026-04-17 (estimated)
Study Completion	2026-09-16 (estimated)
Updated on ClinicalTrials.gov	2025-09-29