NCT07585643Not yet recruiting
IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 6 May 2026
- Start date
- 3 Sept 2026
- Primary completion date
- 3 Sept 2029
- Lead sponsor
- Telethon Kids Institute
- Diseases
- Epilepsy
- NCT number
- NCT07585643
What you commit to
- Study type: Observational
- Planned participants: 40
- From 3 Sept 2026 to the primary completion date, 3 Sept 2029
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Language barriers impeding data collection
- Department for Child Protection and Family Support is involved in the care of the child.
Who the study is looking for
- Children (\<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).
Age in the registry: 0 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Hospital das Clinicas, São Paulo, Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.