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NCT00136136 Clinical Trial

Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children

Behavior Clinical Trial

Official title:
Validation of BIS-monitor in 3 Groups of Newborn Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00136136
Other study ID # 2003/139
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2003
Est. completion date December 31, 2004

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 31, 2004
Est. primary completion date December 31, 2004
Accepts healthy volunteers No
Gender All
Age group 1 Minute and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of the Bispectral Index(BIS)-Monitor Validation of the Bispectral Index(BIS)-Monitor by registration of the bispectral index and spectral edge frequency in relation to behavioural state Short after birth of the newborn
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