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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Behavior

Treatments: Procedure: Registration of the bispectral index and spectral edge frequency

Study type: Observational

Funder types: Other

Identifiers

NCT00136136

2003/139

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 1+ minute old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 3 patient groups

Normal healthy term newborn

Description:

Normal healthy term newborns

Treatment:

Procedure: Registration of the bispectral index and spectral edge frequency

Ill term newly born without brain damage

Description:

Ill term newly borns without brain damage

Treatment:

Procedure: Registration of the bispectral index and spectral edge frequency

Preterm newly born without brain damage

Description:

Preterm newly borns without brain damage

Treatment:

Procedure: Registration of the bispectral index and spectral edge frequency