Early Development of Sleep-wake Cycles in Premature Infants and Its Impact on Neurodevelopmental Outcome (SWC)
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Purpose
Due to the development of neonatal intensive care the number of surviving premature infants increased significantly. The immature brain undergoes a fair amount of external stimuli, which have a great impact on later cognitive development. Increasingly data show, that a delayed emergence of sleep-wake-cycling in newborns can be the first sign of brain injury. Studies have shown that clearly defined sleep states can be identified from 31-32 weeks of gestation onwards. But a few studies show, that also extremely premature infants already show cyclical variations of the background pattern within amplitude-integrated EEG (aEEG= a time-compressed, simplified EEG) and conventional EEG. This might resemble early sleep-wake-states and their presence correlates to the integrity of the central nervous system, although no clearly defined "sleep states" according to the classical definition can be identified. Complex EEG analysis needs the use of automated methods to exclude personal bias and to ensure gestational age specific data analysis. The newly developed NLEO algorithm was specially designed for EEG analysis of premature infants. Conventional EEG within this study will be analyzed visually and with the automated algorithm. In our research project we will study the emergence of Sleep-wake-cycling in extremely premature infants and its impact on their neurodevelopmental outcome prospectively. The different sleep and wake states will be derived from analysis of the conventional Video-EEG, aEEG and polysomnographic measurements. Visual analysis will include assessment of amplitudes and frequencies as well as the latencies and durations of EEG-Bursts and Interburst intervals. The automated NLEO-algorithm will be firstly used for comparison with above described visual analysis and secondly to find regions of interest involved in the organization of these early sleep states. The aim of this study is first to understand and analyze in detail the emergence of sleep-wake cycling including its disturbances in premature infants and to compare automated NLEO algorithm to conventional visual analysis methods. Secondly to correlate neurodevelopmental outcome to the emergence of sleep-wake-cycling.
| Condition | Intervention |
|---|---|
|
Sleep Disorders, Circadian Rhythm |
Other: aEEG and conventional EEG measurement |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Early Development of Sleep-wake Cycles in Premature Infants and Its Impact on Neurodevelopmental Outcome |
- description of Sleep-wake-cycles in aEEG and conventional EEG [ Time Frame: 2 years ] [ Designated as safety issue: No ]parallel assessment of sleep-wake cycles in aEEG and conventional EEG
- Correlation of occurrance of sleep-wake-cycles to neurodevelopmental outcome [ Time Frame: 4 years ] [ Designated as safety issue: No ]correlation of sleep-wake-cycles to Bayley Scales of Infant Development assessed at the age of 2 years
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
preterm cohort
preterm infants born at medical university of vienna and born at gestational age 23+0 - 28+6 weeks of gestation intervention: aEEG and conventional EEG measurements will be performed every two weeks untill 36 weeks of gestation
|
Other: aEEG and conventional EEG measurement
aEEG and conventional EEG measurement including video-polysomnography
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 23 Weeks to 29 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: preterm infant born below 29+0 weeks
Exclusion Criteria:
severe cerebral malformation
Contacts and Locations| Austria | |
| Medical University Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Katrin Klebermass-Schrehof, MD 0043/1/40400/2930 katrin.klebermass-schrehof@meduniwien.ac.at | |
| Principal Investigator: Katrin Klebermass-Schrehof, MD | |
| Principal Investigator: | Katrin Klebermass-Schrehof, MD | Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Katrin Klebermass-Schrehof, MD, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01774318 History of Changes |
| Other Study ID Numbers: | KKS-01-2012 |
| Study First Received: | January 4, 2013 |
| Last Updated: | January 20, 2013 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
sleep-wake-cycles preterm infants aEEG conventional EEG polysomnography |
Additional relevant MeSH terms:
|
Sleep Disorders Parasomnias Sleep Disorders, Circadian Rhythm Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Mental Disorders Chronobiology Disorders Dyssomnias Occupational Diseases |
ClinicalTrials.gov processed this record on May 16, 2013