NCT02890251已完成不适用
Visual Maturation in Premature Newborns According to Factors Influencing Its Development
Central Hospital, Nancy, France0 个研究点目标入组 69 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 主要终点
- Measurement of Visual Acuity by Baby Vision Cards
研究概览
简要总结
The purpose is to describe the level of visual maturation of premature newborns at term equivalent age.
The secondary purpose is to determine factors associated to an altered level of visual maturation, through an exploratory approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy
排除标准
- •Parental opposition
- •Ocular malformation
- •Face malformation
- •Cranial stenosis
- •Chromosomal abnormality
结局指标
主要结局
Measurement of Visual Acuity by Baby Vision Cards
时间窗: Baseline
Baby Vision cards are the French equivalent of Teller Cards - The measurement will be done at the term equivalent age : at the inclusion
次要结局
- Presence, absence of light reflex by clinical evaluation(Baseline)
- Presence, absence or abnormality of visual fixation by clinical observation(Baseline)
- Control of the Retina by Retinal Camera(Baseline)
- Measurement of cycloplegic refraction by mydriaticum 0.5%(Baseline)
- Analysis of visual cortex with MRI(Baseline)
研究者
Jean-Michel HASCOET
Professor
Central Hospital, Nancy, France
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