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Prematurity Related Risks of Cognitive Impairment at School Age (NEORIS)

2015年4月7日 更新者:Jean Michel Hascoet

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nancy、法国、54001
        • M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
      • Nancy、法国、54035
        • Maternite Regionale Univesitaire

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 11年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • Any neurological sequelae

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Former premature infants
Cognitive and executive evaluation by Wechsler IV tests
Children born prematurely in a 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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cognitive and executive functions at school age in prematurely born children
大体时间: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.

Children at the age of 8-11 years

次要结果测量

结果测量
措施说明
大体时间
Quality of parent and children relationship
大体时间:Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
Evaluated at 8-11 years of children (at the time of child cognitive evaluation)

其他结果措施

结果测量
措施说明
大体时间
Utilization of care resources
大体时间:Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
anthropologic study of care and utilization of care resources using semi-directive interviews of caregivers involved in the follow-up network
Evaluation of care network up to 18 months (within the time for children cognitive evaluation)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jean-Michel HASCOET, MD、Maternite Regionale Universitaire CHU NANCY

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2014年1月27日

首先提交符合 QC 标准的

2014年2月3日

首次发布 (估计)

2014年2月4日

研究记录更新

最后更新发布 (估计)

2015年4月8日

上次提交的符合 QC 标准的更新

2015年4月7日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

早产的并发症的临床试验

Cognitive evaluation (Wechsler IV tests)的临床试验

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