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

Vision Clinical Trial

— fVEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00768586
• Other study ID #: MUVienna
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2008
• Last updated: October 14, 2008
• Start date: February 2008

Study information

• Verified date: September 2008
• Source: Medical University of Vienna
• Contact: Katrin Klebermass, MD,
• Phone: 0043140400
• Email: katrin.klebermasz[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Weeks to 29 Weeks

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vision

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Pediatrics, Neonatology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.		Until term	No