A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Study the impact of moderate prematurity on speech encoding characteristics development
研究概览
简要总结
Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea.
In our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. This work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding.
The identification of markers to predict language development is essential for the screening of these children at risk of language delay. These children could thus benefit from early adapted care even before the appearance of language deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeks gestational age, GA)
- •Birth weight appropriate to gestational age determined by WHO growth charts (weight, height, head circumference)
- •Normal clinical examination at inclusion.
- •Written informed consent obtained from both parents (or single parent if single parent)
- •Infant with at least one parent who speaks and understands fluent French
- •Infant is affiliated with the social security system
- •Infant whose parents reside in Marseille
排除标准
- •Neonatal distress (Apgar score < 7)
- •Hypoxic and ischemic encephalopathy
- •Perinatal acidosis
- •Intrauterine growth retardation
- •Brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia)
- •Cerebral congenital malformations
- •Neonatal epilepsy
- •Any condition that in the opinion of the investigator would not be compatible with the conduct of this study
- •Abnormal hearing test performed as part of the child's routine care at birth,
研究组 & 干预措施
Longitudinal follow-up
Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months
干预措施: Electroencephalography (Other)
结局指标
主要结局
Study the impact of moderate prematurity on speech encoding characteristics development
时间窗: 24 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
时间窗: 40 amenorrhea weeks
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
时间窗: 3 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
时间窗: 6 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
时间窗: 10 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
时间窗: 18 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
次要结局
未报告次要终点