Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants

• Conditions: Premature - Weight 1000g-2499g or Gestation of 28-37weeks; Intrauterine Growth Restriction; Neurodevelopmental Disorder; EEG; Spikes, Centrotemporal, Epilepsy of Childhood
• Interventions: Other: aEEG

• Registration Number: NCT01942525
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2013-08-24
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted QC: 2013-09-13
• Last Update Submitted: 2013-09-13
• Study First Posted: 2013-09-16
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• preterm infants below 30 weeks of gestation

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Exclusion Criteria

• congenital anomalies
• severe asphyxia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intrauterine growth restriction	aEEG	birth weight \<10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
Appropriate for gestation age	aEEG	control group with birth weight \>10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up

Primary Outcome Measures

Name	Time	Method
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)	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 Outcome Measures

Name	Time	Method
Neurodevelopmental outcome	24 months	composite score: Bayley Scales of Infant Development (\>85= normal, \<70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal)

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria