Early Development of Sleep-wake Cycles in Premature Infants and Its Impact on Neurodevelopmental Outcome

NCT01774318 | Unknown

• 1 other identifier: KKS-01-2012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disorders, Circadian Rhythm

Keywords

sleep-wake-cycles; preterm infants; aEEG; conventional EEG; polysomnography

Outcome Measures

Primary Outcomes (1)

• description of Sleep-wake-cycles in aEEG and conventional EEG

  parallel assessment of sleep-wake cycles in aEEG and conventional EEG

  2 years

Secondary Outcomes (1)

• Correlation of occurrance of sleep-wake-cycles to neurodevelopmental outcome

  4 years

Study Arms (1)

preterm cohort

OTHER

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

Interventions

aEEG and conventional EEG measurement OTHER

aEEG and conventional EEG measurement including video-polysomnography

preterm cohort

Eligibility Criteria

• Age: 23 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• severe cerebral malformation

Sponsors & Collaborators

• Medical University of Vienna: lead
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Katrin Klebermass-Schrehof, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 24, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

AU (1)