Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date July 31, 2008
First Posted Date August 5, 2008
Last Update Posted Date August 7, 2008
Study Start Date January 2000
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2008)
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis [ Time Frame: 8-12 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2008)
neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development [ Time Frame: three years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
Official Title Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Brain Activity
  • Neurodevelopmental Outcome
Intervention Device: aEEG recording
weekly recordings with aEEG
Other Name: 1 - all infants < 30 weeks gestational age
Study Groups/Cohorts 1
all infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002)
Intervention: Device: aEEG recording
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 31, 2008)
284
Original Actual Enrollment Same as current
Actual Study Completion Date July 2006
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • gestational age < 30 weeks

Exclusion Criteria:

  • brain malformation
  • inborn error of metabolism
Sex/Gender
Sexes Eligible for Study: All
Ages 23 Weeks to 29 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT00728234
Other Study ID Numbers Klebermass_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr.Katrin Klebermass, Univ.Prof.Dr.Manfred Weninger, Medical University Vienna, Department of Pediatrics
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Study Chair: Arnold Pollak, MD, PhD Medical University Vienna, Head of Department of Pediatrics
PRS Account Medical University of Vienna
Verification Date July 2008