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IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).

Study acronym: IBIS
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later May 20, 2029 → Sep 3, 2029
See other at-risk trials from Telethon Kids Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: May 20, 2026 to Sep 3, 2026
    • Primary completion pushed from May 20, 2029 to Sep 3, 2029
    • Study completion pushed from Jun 20, 2029 to Sep 4, 2029
    v3
  2. Study description revisedv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications. Children with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.
Trial Details
NCT Number NCT07585643
Lead Sponsor Telethon Kids Institute
Collaborators: Child and Adolescent Health Service - Perth, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, University of Sao Paulo General Hospital
Conditions
(from sponsor)		 Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm, Developmental and Epileptic Encephalopathies
Related terms Infantile Epileptic-Dyskinetic Encephalopathy, Spasms, Infantile
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov