Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation (fVEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00768586|
Recruitment Status : Unknown
Verified September 2008 by Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : October 8, 2008
Last Update Posted : October 15, 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
|Study Start Date :||February 2008|
Extreme premature infants under the 28th week of gestation.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768586
|Contact: Katrin Klebermass, MD,||0043140400 ext firstname.lastname@example.org|
|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|
|Principal Investigator:||Manfred Weninger, MD, PhD.||MUV|