BehaviorNCT00136136
Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
An observational study of Behavior, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state. Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Behavior
- What is being tested?
- Registration of the bispectral index and spectral edge frequency
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2003to 31 Dec 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newborn children
Who may be able to join
- Group 1: normal healthy term newborns
- Group 2: Ill term newborns without brain damage
- Group 3: Preterm newborns without brain damage
Who cannot join
- Abnormal brain ultrasound
- Abnormal neurological examination
- Major congenital abnormalities
- Use of analgesics, sedatives, antiepileptic drugs or curarisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Behavior
- Being tested
- Registration of the bispectral index and spectral edge frequency
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of the bispectral index and spectral edge frequencyProcedure or surgery
Registration of the bispectral index and spectral edge frequency
| Study group | Role | What they receive |
|---|---|---|
| Normal healthy term newborn | Normal healthy term newborns Receives: Procedure: Registration of the bispectral index and spectral edge frequency | |
| Ill term newly born without brain damage | Ill term newly borns without brain damage Receives: Procedure: Registration of the bispectral index and spectral edge frequency | |
| Preterm newly born without brain damage | Preterm newly borns without brain damage Receives: Procedure: Registration of the bispectral index and spectral edge frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Short after birth of the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study start1 Aug 2003
- Primary completion31 Dec 2004
- Study completion31 Dec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudine De Praeter, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136136
- Sponsor's protocol ID
- 2003/139
- Status last verified
- Dec 2022
- First submitted
- 25 Aug 2005
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of BIS-monitor in 3 Groups of Newborn Children
- ClinicalTrials.gov ID
- NCT00136136
- Acronym / sponsor ID
- 2003/139
- Conditions
- Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Aug 2003 (actual)
- Primary completion
- 31 Dec 2004 (actual)
- Study completion
- 31 Dec 2004 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal healthy term newborn | – | Procedure: Registration of the bispectral index and spectral edge frequencyNormal healthy term newborns |
| Ill term newly born without brain damage | – | Procedure: Registration of the bispectral index and spectral edge frequencyIll term newly borns without brain damage |
| Preterm newly born without brain damage | – | Procedure: Registration of the bispectral index and spectral edge frequencyPreterm newly borns without brain damage |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborn children
Key inclusion criteria (3 listed)
- Group 1: normal healthy term newborns
- Group 2: Ill term newborns without brain damage
- Group 3: Preterm newborns without brain damage
Key exclusion criteria (4 listed)
- Abnormal brain ultrasound
- Abnormal neurological examination
- Major congenital abnormalities
- Use of analgesics, sedatives, antiepileptic drugs or curarisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registration of the bispectral index and spectral edge frequencyRegistration of the bispectral index and spectral edge frequency | Procedure or surgery | Ill term newly born without brain damage, Normal healthy term newborn, Preterm newly born without brain damage |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudine De Praeter, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Bispectral Index(BIS)-Monitor (time frame: Short after birth of the newborn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.