Actively Recruiting
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Led by Vanderbilt University Medical Center · Updated on 2025-09-29
372
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 44 weeks post-menstrual age and 11 years
- Planned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt
- Require mechanical ventilation and sedation
You will not qualify if you...
- Receiving continuous sedation for more than 72 hours before screening
- Rapidly resolving respiratory failure with planned immediate liberation from mechanical ventilation
- Severe developmental delay defined as a score of 4 or higher on the Pediatric Cerebral Performance Category Scale
- Clinically significant 2nd or 3rd degree heart block or bradycardia below 60 beats per minute
- Benzodiazepine dependency requiring ongoing continuous infusion
- Inability to co-enroll with another study
- Expected death or planned withdrawal of support within 24 hours of enrollment
- Bilateral vision loss
- Deafness preventing delirium evaluation
- Inability to understand English that prevents delirium evaluation unless translation services are available
- Documented allergy to dexmedetomidine or midazolam
- Need for continuous neuromuscular blockade infusion planned for at least 48 hours at screening
- Inability to start informed consent within 72 hours of meeting all inclusion criteria
- Adjusted dosing weight over 50 kg at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
H
Heidi Smith, MD, MSCI
CONTACT
R
Rebecca Abel, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here