Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
| Tracking Information | |||||
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| First Received Date ICMJE | July 31, 2008 | ||||
| Last Updated Date | August 6, 2008 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | December 2002 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00728234 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [ Time Frame: three years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants | ||||
| Official Title ICMJE | Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age | ||||
| Brief 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. 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | inclusion of all preterm infants born below 30 weeks gestational age within the study period at medical university vienna |
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| Condition ICMJE |
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| Intervention ICMJE | Device: aEEG recording
weekly recordings with aEEG
Other Name: 1 - all infants < 30 weeks gestational age |
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| Study Group/Cohort (s) | 1
all infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002)
Intervention: Device: aEEG recording |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 284 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | December 2002 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 23 Weeks to 29 Weeks | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00728234 | ||||
| Other Study ID Numbers ICMJE | Klebermass_01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr.Katrin Klebermass, Univ.Prof.Dr.Manfred Weninger, Medical University Vienna, Department of Pediatrics | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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