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Clinical Trials/NCT01942525
NCT01942525
Unknown
Not Applicable

Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants

Medical University of Vienna1 site in 1 country156 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrauterine Growth Restriction
Sponsor
Medical University of Vienna
Enrollment
156
Locations
1
Primary Endpoint
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
Last Updated
12 years ago

Overview

Brief Summary

Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.

Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
September 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katrin Klebermass-Schrehof

MD

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • preterm infants below 30 weeks of gestation

Exclusion Criteria

  • congenital anomalies
  • severe asphyxia

Outcomes

Primary Outcomes

aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)

Time Frame: first 14 days of life

composite score background activity (BA), occurrence of sleep-wake-cycling (SWC) and presence of seizure activity (SA) meaning score 1= normal (normal BA, SWC yes, SA no) and score 2 and 3 = abnormal (2=abnormality in 1 category (BA, SWC or SA) and score 3= abnormality in 2 or 3 categories

Secondary Outcomes

  • Neurodevelopmental outcome(24 months)

Study Sites (1)

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