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临床试验/NCT02054507
NCT02054507已完成不适用

Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment

Jean Michel Hascoet4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年4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
100
试验地点
4
主要终点
Cognitive and executive functions at school age in prematurely born children

研究概览

简要总结

The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.

The study will be divided into 3 parts:

  1. Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
  2. The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
  3. An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

详细描述

Long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment.

Thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources.

The study will be divided into 3 parts:

  1. Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
  2. The quality of parent and child relationship will be evaluated by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
  3. An anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. This part will use semi-directive interviews of caregivers involved in the follow-up network.

This study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Former premature infants aged 8-11 years
  • School grade appropriate for their age
  • Schoolmate control children born at term aged 8-11 years

排除标准

  • Any neurological sequelae

结局指标

主要结局

Cognitive and executive functions at school age in prematurely born children

时间窗: Children at the age of 8-11 years

Assessment by WECHSLER IV tests of children born prematurely without neurological or sensorial sequelae, and without psychological difficulties; All in school grade appropriate for their ages Controls : children born at term, matched for age and school grade.

次要结局

  • Quality of parent and children relationship(Evaluated at 8-11 years of children (at the time of child cognitive evaluation))

研究者

发起方
Jean Michel Hascoet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Michel Hascoet

Professor

Maternite Regionale Universitaire

研究点 (4)

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