Actively Recruiting
Maximizing Efficacy of Goal-Directed Sedation to Reduce Neurological Dysfunction in Mechanically Ventilated Infants and Children Study
Led by Vanderbilt University Medical Center · Updated on 2025-09-29
372
Participants Needed
1
Research Sites
21 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
Researchers are studying sedation in ventilated pediatric patients who often experience delirium, a serious brain dysfunction linked to higher risks of death and longer hospital stays. This trial compares two sedative medications, dexmedetomidine and midazolam, to find which better reduces delirium and improves recovery of brain function, mental health, and physical abilities in children recovering from critical illness. The study is a randomized, phase 3 trial focusing on infants and children up to 11 years old in intensive care. Participants will be randomly assigned to receive either dexmedetomidine or midazolam through continuous intravenous infusion while on mechanical ventilation in the ICU. The doses will be adjusted to reach a target sedation level set by clinicians. Dexmedetomidine doses range from 0.2 to 2.0 mcg/kg/hour, and midazolam doses range from 0.025 to 0.25 mg/kg/hour. Sedation will continue for up to 10 days during ICU stay and mechanical ventilation. Patients will be closely monitored for delirium twice daily for up to 14 days using age-appropriate assessment tools. Cognitive, functional, and psychological health will be evaluated at enrollment, hospital discharge, and six months after ICU discharge. Blood samples will be taken on days 1, 3, and 5 to measure inflammation and brain injury markers. Researchers will also track ventilation duration, ICU and hospital stay lengths, and safety outcomes, with follow-up lasting up to six months after hospital discharge.
CONDITIONS
Brief Title
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged from 44 weeks post-menstrual age to 11 years
- Planned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt
- Require mechanical ventilation and sedation
- Typically pre-pubescent children under 11 years of age
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 with a Pediatric Cerebral Performance Category score of 4 or higher
- Clinically significant 2nd or 3rd degree heart block or bradycardia below 60 beats per minute
- Benzodiazepine dependency requiring continuous infusion
- Inability to co-enroll with another study
- Expected death or withdrawal of support within 24 hours of enrollment
- Bilateral vision loss
- Deafness preventing delirium evaluation
- Inability to understand English without available translation services
- Documented allergy to dexmedetomidine or midazolam
- Medical need for continuous neuromuscular blockade planned for at least 48 hours
- Inability to start informed consent within 72 hours of meeting 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
Your Study Journey
Duration - Up to 72 hours before enrollment
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 10 days or until mechanical ventilation ends
Participants receive continuous sedation with either dexmedetomidine or midazolam while mechanically ventilated in the pediatric ICU. Sedation dose is adjusted to achieve a target sedation level.
Continuous monitoring in the ICU during sedation
Duration - 6 months post ICU discharge
After ICU discharge, participants undergo assessments of cognition, functional status, and psychological health at hospital discharge and 6 months later.
2 in-person visits (hospital discharge and 6 months post discharge)
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
R
Rebecca Abel, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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