Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Ghent

Conditions:

Behavior

Eligibility:

All Genders

1+ years

Brief Summary

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

Eligibility Criteria

Inclusion

  • Group 1: normal healthy term newborns
  • Group 2: Ill term newborns without brain damage
  • Group 3: Preterm newborns without brain damage

Exclusion

  • Abnormal brain ultrasound
  • Abnormal neurological examination
  • Major congenital abnormalities
  • Use of analgesics, sedatives, antiepileptic drugs or curarisation

Key Trial Info

Start Date :

August 1 2003

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2004

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00136136

Start Date

August 1 2003

End Date

December 31 2004

Last Update

December 22 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Hospital Ghent

Ghent, Belgium, 9000