Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04801589 · ClinicalTrials.gov registry record · Phase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
A Phase 3 study of Post Traumatic Stress Disorder and Critical Illness, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 372
- Enrollment target
- 1
- Study location
NCT04801589 is a Phase 3 study of Post Traumatic Stress Disorder and Critical Illness that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 372 participants, below the 1,114-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04801589, a Phase 3 study of Post Traumatic Stress Disorder and Critical Illness, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 372 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2026-09-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04801589
The ClinicalTrials.gov registry entry for NCT04801589 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,114-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (67% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT04801589 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04801589 about?
NCT04801589 is a clinical study titled "Goal-Directed Sedation in Mechanically Ventilated Infants and Children". 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...
What is the current status of trial NCT04801589?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2021-05-10. Estimated completion is 2026-09-16.
What conditions does trial NCT04801589 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Critical Illness, Delirium, Executive Dysfunction, Sedation Complication.
What interventions are being tested in trial NCT04801589?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT04801589?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04801589 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
RECRUITING · Phase 3
-
MDMA-assisted Massed Prolonged Exposure for PTSD
RECRUITING · Phase 3
-
Frontline Clinician Psilocybin Study
COMPLETED · Phase 3
-
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
COMPLETED · Phase 3
-
Comparison of Videoconference and Face-to-Face Delivery of Cognitive Processing Therapy for Posttraumatic Stress Disorder
COMPLETED · Phase 3
-
Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)
COMPLETED · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.