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

NCT ID: NCT00728234

Last Updated: 2008-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Brain Activity Neurodevelopmental Outcome

Keywords

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aEEG preterm infants predictive value outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

all infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002)

aEEG recording

Intervention Type DEVICE

weekly recordings with aEEG

Interventions

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aEEG recording

weekly recordings with aEEG

Intervention Type DEVICE

Other Intervention Names

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1 - all infants < 30 weeks gestational age

Eligibility Criteria

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Inclusion Criteria

* gestational age \< 30 weeks

Exclusion Criteria

* brain malformation
* inborn error of metabolism
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

29 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University Vienna, Department of Pediatrics

Principal Investigators

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Arnold Pollak, MD, PhD

Role: STUDY_CHAIR

Medical University Vienna, Head of Department of Pediatrics

Locations

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Medical University

Vienna, , Austria

Site Status

Countries

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Austria

References

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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: 10.1203/PDR.0b013e31821ba200.

Reference Type DERIVED
PMID: 21436758 (View on PubMed)

Other Identifiers

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Klebermass_01

Identifier Type: -

Identifier Source: org_study_id