Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
Completed
- Conditions
- Behavior
- Interventions
- Procedure: Registration of the bispectral index and spectral edge frequency
- Registration Number
- NCT00136136
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Group 1: normal healthy term newborns
- Group 2: Ill term newborns without brain damage
- Group 3: Preterm newborns without brain damage
Exclusion Criteria
- Abnormal brain ultrasound
- Abnormal neurological examination
- Major congenital abnormalities
- Use of analgesics, sedatives, antiepileptic drugs or curarisation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Normal healthy term newborn Registration of the bispectral index and spectral edge frequency Normal healthy term newborns Ill term newly born without brain damage Registration of the bispectral index and spectral edge frequency Ill term newly borns without brain damage Preterm newly born without brain damage Registration of the bispectral index and spectral edge frequency Preterm newly borns without brain damage
- Primary Outcome Measures
Name Time Method Validation of the Bispectral Index(BIS)-Monitor Short after birth of the newborn Validation of the Bispectral Index(BIS)-Monitor by registration of the bispectral index and spectral edge frequency in relation to behavioural state
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium