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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00768586
Other study ID # MUVienna
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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