RECRUITING

Goal-Directed Sedation in Mechanically Ventilated Infants and Children

Conditions

Delirium Critical Illness Sedation Complication Executive Dysfunction Post Traumatic Stress Disorder pediatrics critical care agitation sedation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-10

Study Completion:2026-09-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04801589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:44 Weeks to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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. Pre-pubescent children (\<11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction.	1. Receiving continuous sedation for \> 72 hours prior to screening. 2. Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV. 3. Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness. 4. Clinically significant 2nd or 3rd degree heart block or bradycardia \< 60 beats per minute. 5. Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion). 6. Inability to co-enroll with another study. 7. Expected death or care plan for withdrawal of support measures within 24 hours of enrollment. 8. Bilateral vision loss. 9. Deafness that will preclude delirium evaluation. 10. Inability to understand English that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and/or translation services are actively available in that particular language. 11. Documented allergy to either dexmedetomidine or midazolam. 12. Medical requirement of continuous (infusion) neuromuscular blockade administration that is planned ongoing for at least 48 hours at time of screening. 13. Inability to start the informed consent process within the 72 hours from the time that all inclusion criteria were met (possible reasons): 1. Attending physician refusal 2. 72-hour period of eligibility was exceeded before the patient was enrolled 3. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) refusal 4. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) unavailable 5. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) is non-English speaking and available research staff is not proficient and/or translation services are not available in that particular language. 14. Adjusted dosing weight is \> 50 kg at time of screening.

Inclusion Criteria

Exclusion 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. Pre-pubescent children (\<11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction.

1. Receiving continuous sedation for \> 72 hours prior to screening.
2. Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV.
3. Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness.
4. Clinically significant 2nd or 3rd degree heart block or bradycardia \< 60 beats per minute.
5. Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion).
6. Inability to co-enroll with another study.
7. Expected death or care plan for withdrawal of support measures within 24 hours of enrollment.
8. Bilateral vision loss.
9. Deafness that will preclude delirium evaluation.
10. Inability to understand English that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and/or translation services are actively available in that particular language.
11. Documented allergy to either dexmedetomidine or midazolam.
12. Medical requirement of continuous (infusion) neuromuscular blockade administration that is planned ongoing for at least 48 hours at time of screening.
13. Inability to start the informed consent process within the 72 hours from the time that all inclusion criteria were met (possible reasons):
1. Attending physician refusal
2. 72-hour period of eligibility was exceeded before the patient was enrolled
3. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) refusal
4. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) unavailable
5. Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) is non-English speaking and available research staff is not proficient and/or translation services are not available in that particular language.
14. Adjusted dosing weight is \> 50 kg at time of screening.

Contacts and Locations

Study Contact

Heidi Smith, MD, MSCI

CONTACT

(615) 936-6808

heidi.smith@vumc.org

Rebecca Abel, MA

CONTACT

(615) 875-3763

rebecca.abel@vumc.org

Principal Investigator

Heidi Smith, MD, MSCI

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Heidi Smith, MD, MSCI, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-10

Study Completion Date2026-09-16

Study Record Updates

Study Start Date2021-05-10

Study Completion Date2026-09-16

Terms related to this study

Keywords Provided by Researchers

pediatrics
critical care
agitation
sedation
delirium

Additional Relevant MeSH Terms

Delirium
Critical Illness
Sedation Complication
Executive Dysfunction
Post Traumatic Stress Disorder