RecruitingPhase 3NCT04801589

Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Maximizing Efficacy of Goal-Directed Sedation to Reduce Neurological Dysfunction in Mechanically Ventilated Infants and Children Study


Sponsor

Vanderbilt University Medical Center

Enrollment

372 participants

Start Date

May 10, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 44 WeeksMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether using a goal-directed sedation approach — adjusting sedation medications based on real-time monitoring of brain activity — is safer and more effective than standard sedation for critically ill infants and children who need a breathing machine. **You may be eligible if...** - Your child is between 44 weeks (from conception) and 11 years old - Your child is admitted to the pediatric intensive care unit (PICU) - Your child requires a ventilator (breathing machine) and sedation medication **You may NOT be eligible if...** - Your child has a condition that prevents safe use of the brain monitoring device - Your child's medical situation makes one of the sedation approaches medically inappropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexmedetomidine

For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr. For example, a 10 kg patient on an infusion of 1 mcg/kg/hr of dexmedetomidine would receive 10 mcg of study drug per hour. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the mini-MENDS study steering committee.

DRUGMidazolam

For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr. For example, a 10 kg patient on an infusion of 0.15 mg/kg/hr of midazolam would receive 1.5 mg of midazolam per hour. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the mini-MENDS study steering committee.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04801589


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