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

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Medical University of Vienna

Status

Unknown

Conditions

Vision

Study type

Observational

Funder types

Other

Identifiers

NCT00768586
MUVienna

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

23 to 29 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

1
Description:
Extreme premature infants under the 28th week of gestation.

Trial contacts and locations

1

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Central trial contact

Katrin Klebermass, MD,

Data sourced from clinicaltrials.gov

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