- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01942525
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical University Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- preterm infants below 30 weeks of gestation
Exclusion Criteria:
- congenital anomalies
- severe asphyxia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intrauterine growth restriction
birth weight <10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
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The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
Other Names:
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Appropriate for gestation age
control group with birth weight >10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
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The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
Time Frame: first 14 days of life
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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
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first 14 days of life
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurodevelopmental outcome
Time Frame: 24 months
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composite score: Bayley Scales of Infant Development (>85= normal, <70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal)
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24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls
Time Frame: 24 months
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morbidities until discharge (Intraventricular hemorrhage, retinopathy, chronic lung disease, necrotizing enterocolitis, periventricular leucomalacia); mortality and neurodevelopmental outcome (via Bayley Scales of Infant Development >85= normal, <70 = severly impaired)
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24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katrin Klebermass-Schrehof, MD, Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KKS-07-2013
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Clinical Trials on Intrauterine Growth Restriction
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Assiut UniversityCompleted
-
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Johns Hopkins UniversityWithdrawnFetal Growth Retardation | Intrauterine Growth Restriction | Intrauterine Growth Retardation | Fetal Growth Restriction
-
Assiut UniversityCompletedIntrauterine Growth Restriction (IUGR)
-
Hospices Civils de LyonUnknown
-
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-
Nantes University HospitalCompletedPlacental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)Preeclampsia and Intrauterine Growth RestrictionFrance
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Ain Shams UniversityCompleted
-
Karadeniz Technical UniversityCompletedIntrauterine Growth Restriction
Clinical Trials on aEEG
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Sang Hoon OhUnknownHeart Arrest | Targeted Temperature ManagementKorea, Republic of
-
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Sheffield Teaching Hospitals NHS Foundation TrustCompleted
-
Medical University of ViennaAustrian Science Fund (FWF)UnknownSleep Disorders, Circadian RhythmAustria
-
Maria Angela FranceschiniEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingPremature Birth | Intracerebral Hemorrhage | Infant, Small for Gestational Age | Extremely Low Birth WeightUnited States
-
St. Justine's HospitalNot yet recruiting
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University of UtahCompletedIntraventricular Hemorrhage | Premature InfantsUnited States
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Medical University of ViennaCompletedBrain Activity | Neurodevelopmental OutcomeAustria
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Cambridge University Hospitals NHS Foundation TrustNorfolk and Norwich University Hospitals NHS Foundation Trust; Luton and Dunstable... and other collaboratorsRecruitingNeonatal SeizuresUnited Kingdom