NCT00728234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
Last Updated

August 7, 2008

Status Verified

July 1, 2008

Enrollment Period

2.9 years

First QC Date

July 31, 2008

Last Update Submit

August 6, 2008

Conditions

Brain ActivityNeurodevelopmental Outcome

Keywords

aEEGpreterm infantspredictive valueoutcome

Outcome Measures

Primary Outcomes (1)

  • amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis

    8-12 weeks

Secondary Outcomes (1)

  • neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development

    three years

Study Arms (1)

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

Interventions

aEEG recordingDEVICE

weekly recordings with aEEG

Also known as: 1 - all infants < 30 weeks gestational age
1

Eligibility Criteria

Age23 Weeks - 29 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • gestational age \< 30 weeks

You may not qualify if:

  • brain malformation
  • inborn error of metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 21436758DERIVED

Study Officials

  • Arnold Pollak, MD, PhD

    Medical University Vienna, Head of Department of Pediatrics

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 5, 2008

Study Start

January 1, 2000

Primary Completion

December 1, 2002

Study Completion

July 1, 2006

Last Updated

August 7, 2008

Record last verified: 2008-07

Locations

AU(1)