Full Text View
Tabular View
No Study Results Posted
Related Studies
Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
This study is currently recruiting participants.
Verified by University Hospital, Ghent, April 2009
First Received: August 25, 2005   Last Updated: April 27, 2009   History of Changes
Sponsored by: University Hospital, Ghent
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00136136
  Purpose

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


Condition Intervention
Behavior
Procedure: Registration of the bispectral index and spectral edge frequency

Study Type: Observational
Official Title: Validation of BIS-Monitor in 3 Groups of Newborn Children

Further study details as provided by University Hospital, Ghent:

Estimated Enrollment: 60
Study Start Date: August 2003
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136136

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

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

Additional Information:
No publications provided

Responsible Party: University Hospital Ghent ( Claudine De Praeter )
Study ID Numbers: 2003/139
Study First Received: August 25, 2005
Last Updated: April 27, 2009
ClinicalTrials.gov Identifier: NCT00136136     History of Changes
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on September 11, 2009