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临床试验/NCT03207477
NCT03207477终止不适用

Visual Maturation in Prematurely Born Infants According to Factors Influencing Its Development. Premavision Follow-up at 18 Months Corrected Age, 4 and 7 Years of Age.

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
37
试验地点
2
主要终点
Visual acuity measurement

研究概览

简要总结

This study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent age (TEA) with factors associated with impaired visual maturation. (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).

In this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Months 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Infants included in the Premavision cohort
  • Term born healthy control infants at matched postnatal age

排除标准

  • Ocular malformation
  • Genetic abnormality
  • Neurodevelopmental impairment

结局指标

主要结局

Visual acuity measurement

时间窗: 7 years post-natal age

Parinaud and Snellen tests

次要结局

  • Measurement of cyclopegic refraction(7 years of age)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Michel HASCOET

Principal Investigator

Central Hospital, Nancy, France

研究点 (2)

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