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Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Study acronym: mini-MENDS
StatusActive, Not Recruiting
PhasePhase 3
Started2021-05-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Oversight, Contacts/Locations v8
Enrollment closed, study ongoing
Completion date2026-09-16→2026-09-30
Study sitesdetails revised at 1 of 1 site
2025-09-23
Study Status, Oversight v7
Re-verified, no change to tracked fields
2024-08-16
Study Status v6
Completion date2027-01-01→2026-09-16
2024-06-06
Study Status v5
Primary completion date2025-06→2026-04-17
Completion date2025-06→2027-01-01
2023-08-11
Study Status, Study Description, Outcome Measures v4
Secondary endpointsdetails revised at 1 of 10 entries
Study description+62 characters
[...] aminobutyric acid (GABA) agonist benzodiazepines. Recently, wethe investigators demonstrated that exposure to the benzodiazepine midazolam [...] osure) with cognitive impairment among pediatric survivors. WeThe investigators, therefore, propose mini-MENDS (Maximizing Efficacy of Goal-Directed Se [...] chanically Ventilated Infants and Children STUDY), in which wethe investigators will determine whether sedation of MV pediatric patients wi [...] ood brain barrier injury (Aim 3). To accomplish these aims, wethe investigators will randomize 372 pediatric patients on MV, aged 44 weeks [...]
Show 3 earlier versions
2023-08-10
Study Status, Study Description, Arms and Interventions, Eligibility v3
Eligibility criteria+125 characters
Inclusion Criteria: Patients will be eligible for enrollment if they are 1) aged ≥44 6weeks monthspost-menstrual age and <up to 11 years, 2) admittedplanned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and 3) onrequiring mechanical ventilation (MV) requiringand sedation. Pre-pubescent children (<11 years) are typically [...] if any one is present: Receiving continuous sedation for > 4872 hours prior to screening. Rapidly resolving respiratory failure at screening, with pl [...] sures within 24 hours of enrollment. Bilateral vision loss. Inability to under [...] [...]
Study description+19 characters
[...] aims, we will randomize 372 pediatric patients on MV, aged 644 monthsweeks post-menstrual age to 11 years, to receive goal-directed continuous sedation w [...]
2022-08-21
Study Status v2
Re-verified, no change to tracked fields
2021-07-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-06→confirmed 2021-05-10
Study sites0→1
2021-03-11
Original filing
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.
Trial Details
NCT Number NCT04801589
Lead Sponsor Vanderbilt University Medical Center
Collaborators: Pfizer, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Delirium, Critical Illness, Sedation Complication, Executive Dysfunction, Post Traumatic Stress Disorder
Enrollment 372 participants
Start Date 2021-05-10
Primary Completion 2026-04-17 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-11