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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00136136
First received: August 25, 2005
Last updated: January 29, 2013
Last verified: January 2013
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of BIS-monitor in 3 Groups of Newborn Children

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Validation of the Bispectral Index(BIS)-Monitor [ Time Frame: Short after birth of the newborn ] [ Designated as safety issue: No ]
    Validation of the Bispectral Index(BIS)-Monitor by registration of the bispectral index and spectral edge frequency in relation to behavioural state


Estimated Enrollment: 60
Study Start Date: August 2003
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00136136     History of Changes
Other Study ID Numbers: 2003/139
Study First Received: August 25, 2005
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014