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Clinical Trials/NCT00768586
NCT00768586
Unknown
Not Applicable

Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation. - A Prospective Study to Identify Normal Values of Flash Visual Evoked Potentials in This Population

Medical University of Vienna1 site in 1 country40 target enrollmentFebruary 2008
ConditionsVision

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vision
Sponsor
Medical University of Vienna
Enrollment
40
Locations
1
Primary Endpoint
Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.
Last Updated
17 years ago

Overview

Brief Summary

The aim of this study is to collect data on the early visual development of extreme premature infants. The method is the measurement of flash visual evoked potentials and the study population includes premature infants under the 28th weeks of gestation, who have normal cranial ultrasound examinations, normal aEEG, no clinical neurological symptoms and who have a normal ophthalmological status.

fVEP measurements were recorded from the first week of life every second week until term.

The fVEP recordings were performed in active sleep, in stable premature infants, who were continuously monitored. The Nihon Kohden Neuropack 8 was used, the stimulus frequency was 0,5 Hz, artefact free averages were analyzed.

The measurements were analyzed according to the presence and absence of known waveforms, their latencies and amplitudes. Longitudinal analysis was performed to analyse the effect of extrauterine visual development on fVEP with growing gestational ages.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
TBD
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • All premature infants under the 29th week of gestation entering our ward.

Exclusion Criteria

  • Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.

Outcomes

Primary Outcomes

Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.

Time Frame: Until term

Study Sites (1)

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