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

NCT07585643 | Not Yet Recruiting

• 1 other identifier: RGS0000008394
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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, we 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.

Conditions

Early Infantile Epileptic Encephalopathy; Infantile Spasm; Developmental and Epileptic Encephalopathies; Epileptic Encephalopathy

Keywords

epileptic encepthalopathy; anaesthesia; PILOT STUDY; MULTICENTRE

Outcome Measures

Primary Outcomes (1)

• Compare pEEG values in awake patients with developmental and epileptic encephalopathies

  pEEG will be measured using Sedline and BIS monitors alongside standard 21-lead EEG.

  60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.

Study Arms (1)

Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause

Children (\<16 years old) with a confirmed diagnosis of early onset epileptic encephalopathy (EE) or Developmental and epileptic encephalopathy (DEE) due to any cause (prior to age 2 years).

Diagnostic Test: Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.

Interventions

Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors. DIAGNOSTIC_TEST

This is an observational study of children under 16 years of age, who will be fitted with a 21-lead EEG and then, in consecutive random order, a BIS or Sedline monitor with measurements taken for 30 minutes with each monitor, 60 min in total. This will allow pEEG data to be measured against a corresponding continuous EEG. The depth of anaesthesia monitors used are Bispectral Index (BIS, Medtronic, Minneapolis, Minnesota, USA) and Sedline (Masimo, Irvine, California, USA).

Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

20 eligible patients identified by the neurology department at Perth Children's Hospital and 20 eligible patients identified by the neurology department at Hospital das Clinicas HCFMUSP, Faculdade de Medicina, will be approached for the study.

You may qualify if:

• Children (\<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).

You may not qualify if:

• Language barriers impeding data collection
• Department for Child Protection and Family Support is involved in the care of the child.

Sponsors & Collaborators

• Telethon Kids Institute: lead
• Child and Adolescent Health Service - Perth: collaborator
• Feculdade de Medicina da Universidade de Sao Paulo - Brasil: collaborator
• Hospital das Clínicas de São Paulo - SP: collaborator

Study Sites (2)

Perth Children's Hospital

Perth, Western Australia, 6909, Australia

Location

Hospital das Clinicas, São Paulo, Sao Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Infantile Epileptic-Dyskinetic Encephalopathy; Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Central Study Contacts

Britta S von Ungern-Sternberg, MD, PhD

CONTACT

+61 8 6456 4806; britta.regli-vonungern@health.wa.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 14, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2029
• Study Completion (Estimated): June 20, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BR (1)