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

December 21, 2022 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborn children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal healthy term newborn
Normal healthy term newborns
Procedure: Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
Ill term newly born without brain damage
Ill term newly borns without brain damage
Procedure: Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency
Preterm newly born without brain damage
Preterm newly borns without brain damage
Procedure: Registration of the bispectral index and spectral edge frequency
Registration of the bispectral index and spectral edge frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the Bispectral Index(BIS)-Monitor
Time Frame: 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
Short after birth of the newborn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Claudine De Praeter, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2003

Primary Completion (Actual)

December 31, 2004

Study Completion (Actual)

December 31, 2004

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2003/139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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