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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00768586
First received: October 7, 2008
Last updated: October 14, 2008
Last verified: September 2008
  Purpose

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.


Condition
Vision

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Groups/Cohorts
1
Extreme premature infants under the 28th week of gestation.

  Eligibility

Ages Eligible for Study:   23 Weeks to 29 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premature infants between the 23-29th week of gestation are included.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768586

Contacts
Contact: Katrin Klebermass, MD, 0043140400 ext 3232 katrin.klebermasz@meduniwien.ac.at

Locations
Austria
Medical University Vienna, Department of Pediatrics, Neonatology Recruiting
Vienna, Austria, 1090
Sub-Investigator: Zsofia Rona, MD         
Principal Investigator: Manfred Weninger, MD, PhD.         
Principal Investigator: Katrin Klebermass, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Manfred Weninger, MD, PhD. MUV
  More Information

No publications provided

Responsible Party: Arnold Pollak, MD, PhD, Medical University Vienna, Head of Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00768586     History of Changes
Other Study ID Numbers: MUVienna
Study First Received: October 7, 2008
Last Updated: October 14, 2008
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on August 20, 2014