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

NCT00768586 | Unknown

• 1 other identifier: MUVienna
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vision

Outcome Measures

Primary Outcomes (1)

• Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.

  Until term

Study Arms (1)

1

Extreme premature infants under the 28th week of gestation.

Eligibility Criteria

• Age: 23 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All premature infants under the 29th week of gestation entering our ward.

You may not qualify if:

• Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna, Department of Pediatrics, Neonatology

Vienna, 1090, Austria

RECRUITING

Study Officials

• Manfred Weninger, MD, PhD.

  MUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Klebermass, MD,

CONTACT

0043140400; katrin.klebermasz@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: February 1, 2008
• Last Updated: October 15, 2008

Record last verified: 2008-09

Locations

AU (1)