Brain ActivityNCT00728234
Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
An observational study of Brain Activity and Neurodevelopmental Outcome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG) tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental outcome at the age of three years. Read more about this study
- Who is it for?
- Ages 23 to 29 weeks
- Conditions the study is for
- Brain Activity, Neurodevelopmental Outcome
- What is being tested?
- aEEG recording
- Type of treatment
- Medical device
- How many people
- 284 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2000to Jul 2006
- 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 23 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Study population: inclusion of all preterm infants born below 30 weeks gestational age within the study period at medical university vienna
Who may be able to join
- gestational age < 30 weeks
Who cannot join
- brain malformation
- inborn error of metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age
The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG) tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental outcome at the age of three years.
Aim of the study was to observe if there is a correlation of the aEEG tracings of the first weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as prognostic tool.
Read the detailed description
From the first week of life on aEEG-recordings were obtained on a weekly basis and the results of the first eight weeks of life were analyzed for this study.
aEEG-tracings were analyzed with regard to background activity (percentages of continuous and discontinuous patterns), the presence/absence of sleep-wake-cycles and the occurrence of seizure activity. These items where summed up in a score including three grades (normal, moderately and severely abnormal).
The aEEG was recorded as a single channel EEG from biparietal surface disk electrodes using a CFM (CFM 5330, Lectromed Devices Ltd., UK) or the CFM 6000 (Olympic Medical, USA). Assessment of neurodevelopmental outcome was done at three years of age by assessment of the Bayley Scales of Infant Development II (BSID-II) During the study period from January 1st 2000, and December 31st 2002 a total of 284 preterm infants less than 30 weeks´ gestational age were admitted to the neonatal intensive care unit of the Medical University of Vienna. Neurodevelopmental outcome could be obtained in 148/284 infants at the age of three years and these infants therefore fulfilled the inclusion criteria for this study
- Conditions
- Brain Activity, Neurodevelopmental Outcome
- Being tested
- aEEG recording
- Keywords
- aEEG, preterm infants, predictive value, outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aEEG recordingDevice
Also called 1 - all infants < 30 weeks gestational age
weekly recordings with aEEG
| Study group | Role | What they receive |
|---|---|---|
| 1 | all infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002) Receives: Device: aEEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis
Measured: 8-12 weeks
Secondary outcomes (1)
neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJan 2000
- Primary completionDec 2002
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ActivityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Arnold Pollak, MD, PhD, Study chair, Medical University Vienna, Head of Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728234
- Sponsor's protocol ID
- Klebermass_01
- Status last verified
- Jul 2008
- First submitted
- 31 Jul 2008
- Last updated
- 7 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Klebermass K, Olischar M, Waldhoer T, Fuiko R, Pollak A, Weninger M. Amplitude-integrated EEG pattern predicts further outcome in preterm infants. Pediatr Res. 2011 Jul;70(1):102-8. doi: 10.1203/PDR.0b013e31821ba200.
PubMed 21436758
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age
- ClinicalTrials.gov ID
- NCT00728234
- Acronym / sponsor ID
- Klebermass_01
- Conditions
- Brain Activity, Neurodevelopmental Outcome
- Keywords
- aEEG, preterm infants, predictive value, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 5 Aug 2008 (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.
The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG) tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental outcome at the age of three years.
Aim of the study was to observe if there is a correlation of the aEEG tracings of the first weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as prognostic tool.
Detailed description
From the first week of life on aEEG-recordings were obtained on a weekly basis and the results of the first eight weeks of life were analyzed for this study.
aEEG-tracings were analyzed with regard to background activity (percentages of continuous and discontinuous patterns), the presence/absence of sleep-wake-cycles and the occurrence of seizure activity. These items where summed up in a score including three grades (normal, moderately and severely abnormal).
The aEEG was recorded as a single channel EEG from biparietal surface disk electrodes using a CFM (CFM 5330, Lectromed Devices Ltd., UK) or the CFM 6000 (Olympic Medical, USA). Assessment of neurodevelopmental outcome was done at three years of age by assessment of the Bayley Scales of Infant Development II (BSID-II) During the study period from January 1st 2000, and December 31st 2002 a total of 284 preterm infants less than 30 weeks´ gestational age were admitted to the neonatal intensive care unit of the Medical University of Vienna. Neurodevelopmental outcome could be obtained in 148/284 infants at the age of three years and these infants therefore fulfilled the inclusion criteria for this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: aEEG recordingall infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002) |
Who may qualify
- Ages
- 23 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- inclusion of all preterm infants born below 30 weeks gestational age within the study period at medical university vienna
Key inclusion criteria (1 listed)
- gestational age < 30 weeks
Key exclusion criteria (2 listed)
- brain malformation
- inborn error of metabolism
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 |
|---|---|---|
| aEEG recordingAlso: 1 - all infants < 30 weeks gestational ageweekly recordings with aEEG | Device | 1 |
Primary outcome
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis
Time frame: 8-12 weeks
1 secondary outcome
neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development
Time frame: three years
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 7 Aug 2008.
- Derived from this study: PubMed 21436758Klebermass K, Olischar M, Waldhoer T, Fuiko R, Pollak A, Weninger M. Amplitude-integrated EEG pattern predicts further outcome in preterm infants. Pediatr Res. 2011 Jul;70(1):102-8. doi: 10.1203/PDR.0b013e31821ba200.
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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.
Arnold Pollak, MD, PhD study chair
Medical University Vienna, Head of Department of Pediatrics
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 Brain Activity and Neurodevelopmental Outcome, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 2 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 7 Aug 2008. 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 Austria. 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?
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728234, which also lists 1 linked publication.
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 7 Aug 2008.