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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00728234
Collaborator
(none)
284
1
78
3.6

Study Details

Study Description

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 Phase
  • 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

Study Design

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 :
Jan 1, 2000
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Jul 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 1 - all infants < 30 weeks gestational age
  • Outcome Measures

    Primary Outcome Measures

    1. amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis [8-12 weeks]

    Secondary Outcome Measures

    1. neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [three years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Weeks to 29 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • gestational age < 30 weeks
    Exclusion Criteria:
    • brain malformation

    • inborn error of metabolism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00728234
    Other Study ID Numbers:
    • Klebermass_01
    First Posted:
    Aug 5, 2008
    Last Update Posted:
    Aug 7, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2008