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Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation (fVEP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Medical University of Vienna.
Recruitment status was:  Recruiting
Information provided by:
Medical University of Vienna Identifier:
First received: October 7, 2008
Last updated: October 14, 2008
Last verified: September 2008

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: February 2008
Extreme premature infants under the 28th week of gestation.


Ages Eligible for Study:   23 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants between the 23-29th week of gestation are included.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00768586

Contact: Katrin Klebermass, MD, 0043140400 ext 3232

Medical University Vienna, Department of Pediatrics, Neonatology Recruiting
Vienna, Austria, 1090
Sub-Investigator: Zsofia Rona, MD         
Principal Investigator: Manfred Weninger, MD, PhD.         
Principal Investigator: Katrin Klebermass, MD         
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Manfred Weninger, MD, PhD. MUV
  More Information

Responsible Party: Arnold Pollak, MD, PhD, Medical University Vienna, Head of Department of Pediatrics Identifier: NCT00768586     History of Changes
Other Study ID Numbers: MUVienna
Study First Received: October 7, 2008
Last Updated: October 14, 2008 processed this record on September 21, 2017