Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Recruiting Phase 3 Interventional Study
Delirium Critical Illness Sedation Complication Executive Dysfunction Post Traumatic Stress Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
44 Weeks – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
372 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients will be eligible for enrollment if they are 1) aged 44 weeks post-menstrual age and up to 11 years, 2) planned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and 3) requiring mechanical ventilation (MV) and sedation. Pr…
Contacts

Heidi Smith, MD, MSCI

(615) 936-6808

heidi.smith@vumc.org

CONTACT

Rebecca Abel, MA

(615) 875-3763

rebecca.abel@vumc.org

CONTACT