Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00136136
First received: August 25, 2005
Last updated: December 4, 2014
Last verified: December 2014

August 25, 2005
December 4, 2014
August 2003
December 2015   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00136136 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
Validation of BIS-monitor in 3 Groups of Newborn Children

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Newborn children

Behavior
Procedure: Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
  • Normal healthy term newborn
    Normal healthy term newborns
    Intervention: Procedure: Registration of the bispectral index and spectral edge frequency
  • Ill term newly born without brain damage
    Ill term newly borns without brain damage
    Intervention: Procedure: Registration of the bispectral index and spectral edge frequency
  • Preterm newly born without brain damage
    Preterm newly borns without brain damage
    Intervention: Procedure: Registration of the bispectral index and spectral edge frequency
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Kris De Coen, MD kris.decoen@UGent.be
Belgium
 
NCT00136136
2003/139
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Claudine De Praeter, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP