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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. Identifier: NCT00728234
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : August 7, 2008
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment
Brain Activity Neurodevelopmental Outcome Device: aEEG recording

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 : Observational
Actual Enrollment : 284 participants
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
Study Start Date : January 2000
Actual Primary Completion Date : December 2002
Actual Study Completion Date : July 2006

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis [ Time Frame: 8-12 weeks ]

Secondary Outcome Measures :
  1. neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [ Time Frame: three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
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

Inclusion Criteria:

  • gestational age < 30 weeks

Exclusion Criteria:

  • brain malformation
  • inborn error of metabolism

Information from the National Library of Medicine

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 identifier (NCT number): NCT00728234

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Medical University
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Study Chair: Arnold Pollak, MD, PhD Medical University Vienna, Head of Department of Pediatrics
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr.Katrin Klebermass, Univ.Prof.Dr.Manfred Weninger, Medical University Vienna, Department of Pediatrics Identifier: NCT00728234    
Other Study ID Numbers: Klebermass_01
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: July 2008
Keywords provided by Medical University of Vienna:
preterm infants
predictive value
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications