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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
History of Changes
  Purpose

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 Intervention
Brain Activity
Neurodevelopmental Outcome
 Device: aEEG recording

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [ Time Frame: three years ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: January 2000
Study Completion Date: July 2006
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

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

  Eligibility

Ages Eligible for Study:   23 Weeks to 29 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • gestational age < 30 weeks

Exclusion Criteria:

  • brain malformation
  • inborn error of metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728234

Locations
Austria
Medical University
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Arnold Pollak, MD, PhD Medical University Vienna, Head of Department of Pediatrics
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr.Katrin Klebermass, Univ.Prof.Dr.Manfred Weninger, Medical University Vienna, Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00728234     History of Changes
Other Study ID Numbers: Klebermass_01
Study First Received: July 31, 2008
Last Updated: August 6, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
aEEG
preterm infants
predictive value
outcome

ClinicalTrials.gov processed this record on June 18, 2013