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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Vision

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Extreme premature infants under the 28th week of gestation.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

23 Weeks

Maximum Eligible Age

29 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Medical University Vienna, Head of Department of Pediatrics

Principal Investigators

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Manfred Weninger, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

MUV

Locations

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Medical University Vienna, Department of Pediatrics, Neonatology

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Katrin Klebermass, MD,

Role: CONTACT

Phone: 0043140400

Email: [email protected]

Other Identifiers

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MUVienna

Identifier Type: -

Identifier Source: org_study_id