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临床试验/NCT04607109
NCT04607109已完成不适用

Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2020年11月2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
238
试验地点
1
主要终点
EDA score (Evaluation Des fonctions cognitives et des Apprentissages)

研究概览

简要总结

Thanks to the evolution in knowledge and technical advances in premature newborn intensive care, the survival of very premature infants is now possible. However, prognosis remain sometimes uncertain.

In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks.

However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties.

In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until they are 7 years old.

The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7.

At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • all children prematurely born between 24 and 33 completed week during 2012
  • and involved in the Lorraine Perinatal Follow-up program at 7 years old

排除标准

  • Children not able to respond to the EDA evaluation

结局指标

主要结局

EDA score (Evaluation Des fonctions cognitives et des Apprentissages)

时间窗: 7 years old

Evaluation of learning ability by a standardized score (ranging from 15 in maths to 65 in reading, the higher score being the better)

次要结局

  • RAFAEL follow-up questionnaire reply of parents(8 years old)

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

Professor

Central Hospital, Nancy, France

研究点 (1)

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