Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00728234|
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : August 7, 2008
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.
|Condition or disease||Intervention/treatment|
|Brain Activity Neurodevelopmental Outcome||Device: aEEG recording|
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 Type :||Observational|
|Actual Enrollment :||284 participants|
|Official Title:||Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||July 2006|
all infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002)
Device: aEEG recording
weekly recordings with aEEG
Other Name: 1 - all infants < 30 weeks gestational age
- amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis [ Time Frame: 8-12 weeks ]
- neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [ Time Frame: three years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728234
|Vienna, Austria, 1090|
|Study Chair:||Arnold Pollak, MD, PhD||Medical University Vienna, Head of Department of Pediatrics|