Intrauterine Growth Restriction Clinical Trial
Official title:
Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
Verified date | September 2013 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 156 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 23 Weeks to 30 Weeks |
Eligibility |
Inclusion Criteria: - preterm infants below 30 weeks of gestation Exclusion Criteria: - congenital anomalies - severe asphyxia |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls | 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) | 24 months | No |
Primary | aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity) | 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 | first 14 days of life | No |
Secondary | Neurodevelopmental outcome | composite score: Bayley Scales of Infant Development (>85= normal, <70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal) | 24 months | No |
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