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

NCT ID: NCT01942525

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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

Keywords

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IUGR aEEG preterm infants neurodevelopmental outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intrauterine growth restriction

birth weight \<10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up

aEEG

Intervention Type OTHER

The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)

Appropriate for gestation age

control group with birth weight \>10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up

aEEG

Intervention Type OTHER

The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)

Interventions

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aEEG

The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)

Intervention Type OTHER

Other Intervention Names

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assessment of neurodevelopmental follow-up

Eligibility Criteria

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Inclusion Criteria

* preterm infants below 30 weeks of gestation

Exclusion Criteria

* congenital anomalies
* severe asphyxia
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Katrin Klebermass-Schrehof

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katrin Klebermass-Schrehof, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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KKS-07-2013

Identifier Type: -

Identifier Source: org_study_id