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

Completed

• Conditions: Neurodevelopmental Outcome; Brain Activity
• Interventions: Device: aEEG recording

• Registration Number: NCT00728234
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2000-01
• Primary Completion: 2002-12
• Study Completion: 2006-07
• Status Verified: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-05
• Last Update Submitted: 2008-08-06
• Last Update Posted: 2008-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• gestational age < 30 weeks

Exclusion Criteria

• brain malformation
• inborn error of metabolism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis	8-12 weeks

Secondary Outcome Measures

Name	Time	Method
neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development	three years

Trial Locations

Locations (1)

Medical University; 🇦🇹 Vienna, Austria