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

Validation of BIS-monitor in 3 Groups of Newborn Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00136136

Enrollment

Registered

2005-08-26

Start date

2003-08-01

Completion date

2004-12-31

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior

Brief summary

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

Interventions

PROCEDURERegistration of the bispectral index and spectral edge frequency

Registration of the bispectral index and spectral edge frequency

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026