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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136136
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 26, 2005
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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Brief Summary:
This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.

Condition or disease Intervention/treatment
Behavior Procedure: Registration of the bispectral index and spectral edge frequency

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of BIS-monitor in 3 Groups of Newborn Children
Study Start Date : August 2003
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015
Groups and Cohorts
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Group/Cohort Intervention/treatment
Normal healthy term newborn
Normal healthy term newborns
 Procedure: 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
 Procedure: 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
 Procedure: Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency


Outcome Measures
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Primary Outcome Measures :
  1. Validation of the Bispectral Index(BIS)-Monitor [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn children
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136136


Contacts
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Contact: Kris De Coen, MD kris.decoen@UGent.be

Locations
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Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Kris De Coen, MD       kris.decoen@UGent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Claudine De Praeter, MD, PhD University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00136136    
Other Study ID Numbers: 2003/139
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014