Clinical Trial

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents

Study acronym: ABOVE
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated February 4, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives. The main question\[s\] it aims to answer are: * Will people join the study? (recruitment) * Will participants finish the study? * Will healthcare teams accept the study procedures? Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-05-10; most recent amendment 2026-02-02.
Status change: Not Yet Recruiting → Recruiting 2023-10-31
Trial Details
NCT Number NCT05867472
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
Enrollment 60 participants
Start Date 2023-10-10
Primary Completion 2026-05 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-04