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
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 23 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All premature infants under the 29th week of gestation entering our ward.
排除标准
- •Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.
结局指标
主要结局
Latency and Amplitude of Visual Evoked Potential waveforms measured in the first week of life than every second week prospectively until term.
时间窗: Until term
次要结局
未报告次要终点