Clinical trial NCT00728234: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Activity
Neurodevelopmental Outcome
Keywords: aEEG
preterm infants
predictive value
outcome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-08-05
Enrollment: 284
Sex: ALL
Minimum age (years): 23
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: Inclusion Criteria:

* gestational age \< 30 weeks

Exclusion Criteria:

* brain malformation
* inborn error of metabolism

Primary outcomes:
measure: amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis
timeFrame: 8-12 weeks
Secondary outcomes:
measure: neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development
timeFrame: three years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University
Study officials:
affiliation: Medical University Vienna, Head of Department of Pediatrics
name: Arnold Pollak, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.