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

Study acronym: ABOVE
StatusRecruiting
PhasePhase 3
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions: Isoflurane Inhalant Product (Drug), Sevoflurane inhalant product (Drug) to Isoflurane Inhalant Product (Drug)
    • Eligibility criteria expanded, about 44 words
    v6
  2. Site contacts updated at 1 of 3 sitesv5
  3. Study sites: 2 to 3
    • Study completion date: May 2026 to Dec 2026
    • Eligibility criteria expanded, about 1 word
    v4
  4. Site details revised at 2 of 2 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2023 to Oct 10, 2023
    • Study sites: 0 to 2
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05867472
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)		 Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
Related terms Respiratory Aspiration
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov