Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00728234
First received: July 31, 2008
Last updated: August 6, 2008
Last verified: July 2008

July 31, 2008
August 6, 2008
January 2000
December 2002   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00728234 on ClinicalTrials.gov Archive Site
neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [ Time Frame: three years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

inclusion of all preterm infants born below 30 weeks gestational age within the study period at medical university vienna

  • Brain Activity
  • Neurodevelopmental Outcome
Device: aEEG recording
weekly recordings with aEEG
Other Name: 1 - all infants < 30 weeks gestational age
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
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: 10.1038/pr.2011.327.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
July 2006
December 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • gestational age < 30 weeks

Exclusion Criteria:

  • brain malformation
  • inborn error of metabolism
Both
23 Weeks to 29 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00728234
Klebermass_01
No
Dr.Katrin Klebermass, Univ.Prof.Dr.Manfred Weninger, Medical University Vienna, Department of Pediatrics
Medical University of Vienna
Not Provided
Study Chair: Arnold Pollak, MD, PhD Medical University Vienna, Head of Department of Pediatrics
Medical University of Vienna
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP