VisionfVEPNCT00768586
Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation
An observational study of Vision, run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 23 to 29 weeks
- Conditions the study is for
- Vision
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants between the 23-29th week of gestation are included.
Who may be able to join
- All premature infants under the 29th week of gestation entering our ward.
Who cannot join
- Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna, Department of Pediatrics, Neonatology
Vienna, 1090
Zsofia Rona, MD
Manfred Weninger, MD, PhD.
About this study
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
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.
Read more
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.
- Conditions
- Vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Extreme premature infants under the 28th week of gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.
Measured: Until term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VisionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Manfred Weninger, MD, PhD., Principal investigator, MUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768586
- Sponsor's protocol ID
- MUVienna
- Acronym
- fVEP
- Status last verified
- Sep 2008
- First submitted
- 7 Oct 2008
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00768586
- Acronym / sponsor ID
- fVEP / MUVienna
- Conditions
- Vision
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2008
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Extreme premature infants under the 28th week of gestation. |
Who may qualify
- Ages
- 23 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants between the 23-29th week of gestation are included.
Key inclusion criteria (1 listed)
- All premature infants under the 29th week of gestation entering our ward.
Key exclusion criteria (1 listed)
- Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Weninger, MD, PhD. principal investigator
MUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Klebermass, MD, (0043140400 ext. 3232, katrin.klebermasz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.