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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01942525
Other study ID # KKS-07-2013
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 24, 2013
Last updated September 13, 2013
Start date June 2010
Est. completion date September 2013

Study information

Verified date September 2013
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Medical University Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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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