Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
研究概览
简要总结
The aim of the study is to assess visual function from neonatal age to 36 months of age in infants at risk of visual impairment due to brain lesion or ocular pathology
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Days 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age
- •Genetic syndroms
- •Hypoxic Hischemic Encephalopathy
- •Brain malformation
- •Metabolic diseases
- •Ocular pathologies
排除标准
- •Patients at low risk of developing neurological outcomes
- •Refusal of informed consent
结局指标
主要结局
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study
时间窗: 5 years
The score of the functional visual assessment will be obtained at neonatal age and at 1-3-6-9-12-18-24-36 months of life will be analysed at each age and compared to neurodevelopment findings using different scales according to age. These results will be related to the MRI total score (obtained by the sum of scores by site: cortex, basal ganglia, white matter and cerebellum, normal (0), mild abnormal (1), severely abnormal (2)).
次要结局
- Correlation betwwen functional visual assessment score to MRI score(5 years)
研究者
Ricci Daniela
Principal Investigator Pediatric Neurologist
Fondazione Policlinico Universitario Agostino Gemelli IRCCS