NCT00136136

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

August 25, 2005

Last Update Submit

December 21, 2022

Conditions

Behavior

Outcome Measures

Primary Outcomes (1)

  • Validation of the Bispectral Index(BIS)-Monitor

    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

Study Arms (3)

Normal healthy term newborn

Normal healthy term newborns

Procedure: 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

Preterm newly born without brain damage

Preterm newly borns without brain damage

Procedure: Registration of the bispectral index and spectral edge frequency

Interventions

Registration of the bispectral index and spectral edge frequencyPROCEDURE

Registration of the bispectral index and spectral edge frequency

Ill term newly born without brain damageNormal healthy term newbornPreterm newly born without brain damage

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newborn children

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Claudine De Praeter, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

August 1, 2003

Primary Completion

December 31, 2004

Study Completion

December 31, 2004

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations

BE(1)