Building the Path to Resilience in Preterm Infants: a Neuroimaging Investigation of the Impact of Multisensory and Neurocognitive Interventions Concern: Mindfulness-based Intervention

Pediatric Clinical Research Platform0 个研究点目标入组 60 人开始时间: 2016年9月1日最近更新: 2020年11月20日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 60
主要终点: KIDSCREEN-27 - Self-reported questionnaire (Robitail et al., 2007)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Neurocognitive disorders now touch 27% of the European population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. Cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. Ramon y Cajal in his studies on the making of the brain clearly stated: "The total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". Understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the National Scientific Council for the Developing Child). Interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. The goal of this study is to test the impact of a Mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. Mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. Overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. Even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 10 Years 至 15 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•born before 32 gestational weeks

排除标准

•severe sensory or physical disabilities (cerebral palsy, blindness, hearing loss)
•intelligence quotient below 70
•not French speaking