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

Completed

• Conditions: Behavior

• Registration Number: NCT00136136
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08-01
• Primary Completion: 2004-12-31
• Study Completion: 2004-12-31
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the Bispectral Index(BIS)-Monitor	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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium