Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
NCT ID: NCT00136136
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2003-08-01
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal healthy term newborn
Normal healthy term newborns
Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
Ill term newly born without brain damage
Ill term newly borns without brain damage
Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
Preterm newly born without brain damage
Preterm newly borns without brain damage
Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
Interventions
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Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
Eligibility Criteria
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Inclusion Criteria
* Group 2: Ill term newborns without brain damage
* Group 3: Preterm newborns without brain damage
Exclusion Criteria
* Abnormal neurological examination
* Major congenital abnormalities
* Use of analgesics, sedatives, antiepileptic drugs or curarisation
1 Minute
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Claudine De Praeter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Website University Hospital Ghent
Other Identifiers
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2003/139
Identifier Type: -
Identifier Source: org_study_id