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CompletedNCT00136136Updated Dec 22, 2022

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

An observational study in Behavior, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 1 Minute and older. Per ClinicalTrials.gov, last updated 2022-12-22.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
1 Minute and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Behavior
03

In context

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newborn children

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

Exclusion Criteria:

  • Abnormal brain ultrasound
  • Abnormal neurological examination
  • Major congenital abnormalities
  • Use of analgesics, sedatives, antiepileptic drugs or curarisation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • 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

  • ProcedureRegistration of the bispectral index and spectral edge frequency

    Registration of the bispectral index and spectral edge frequency

06

What researchers measure

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

    Time frame: Short after birth of the newborn

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00136136
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Aug 26, 2005
Start date
Aug 1, 2003
Primary completion
Dec 31, 2004
Completion
Dec 31, 2004
Last update
Dec 22, 2022

Study contacts

Claudine De Praeter, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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