Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Vanderbilt University Medical Center
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) Pfizer