Status:
COMPLETED
Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
Lead Sponsor:
University Hospital, Ghent
Conditions:
Behavior
Eligibility:
All Genders
1+ years
Brief Summary
This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.
Eligibility Criteria
Inclusion
- Group 1: normal healthy term newborns
- Group 2: Ill term newborns without brain damage
- Group 3: Preterm newborns without brain damage
Exclusion
- Abnormal brain ultrasound
- Abnormal neurological examination
- Major congenital abnormalities
- Use of analgesics, sedatives, antiepileptic drugs or curarisation
Key Trial Info
Start Date :
August 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2004
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00136136
Start Date
August 1 2003
End Date
December 31 2004
Last Update
December 22 2022
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000