Neurodevelopmental Assessment and Parents Feelings at 7-8 Years of Age for Prematurely Born Children Involved in the Réseau Périnatal Lorrain Follow-up Program
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
- 否
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
Jean-Michel HASCOET
Professor
Central Hospital, Nancy, France
