A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neural flexibility
研究概览
简要总结
The overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old).
详细描述
The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 32 Months 至 34 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent has been obtained from the parent/legally acceptable representative.
- •Full-term birth (≥ 37 weeks and ≥ 2.5kg)
- •Typically developing Children aged between 32-34 months (2 years 8 months to 2 years10 month of age) at enrolment
- •Neurotypical development as assessed by interview
- •No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview [defined as a diagnosed learning neurologic or psychiatric disorder in a first degree relative (e.g. parents, siblings)].
- •Dietary requirement detailed below:
- •S-26 GOLD or ULTIMA GUM--fed group:
- •I. Daily consumption of S-26 GOLD or ULTIMA GUM for the last 60 days (2 months) II. Desire of the parent to continue feeding GUM during the course of the study
- •Cow's milk-fed group:
- •I. Daily consumption of cow's milk or for the last 60 days (2 months) II. Desire of the parent to continue feeding cow's milk during the course of the study
排除标准
- •Delayed birth ( > 41 weeks gestation) as reported in medical record
- •Birth Weight < 2500 g or small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight above the 90th percentile) as reported in medical record
- •History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview
- •History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview
- •In utero exposure to alcohol abuse or illicit substances as defined as diagnosis of current substance use disorder in the biological mother and guidelines set by the American College of Obstetricians and Gynecologists and the Royal College of Physicians
- •Multiple birth as reported in medical record
- •Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview/ medical record
- •Abnormal screening laboratory values and studies considered to be clinically significant in the opinion of the Investigator (e.g., metabolic disease screening, neonatal bilirubin)
结局指标
主要结局
Neural flexibility
时间窗: at baseline and 42 months after baseline
MRI-derived neural flexibility associated with cognitive flexibility (including anterior cingulate cortex, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, anterior insula, interior frontal junction, superior parietal lobule, precuneus, intraparietal sulcus, and temporoparietal junction)
Global Executive Composite (GEC) score
时间窗: at baseline and 42 months of age
executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale
次要结局
- Brain structure (brain regions volume)(at baseline and 42 months of age)
- Brain structure (cortical surface area)(at baseline and 42 months of age)
- Brain structure (cortical thickness)(at baseline and 42 months of age)
- Brain structure (myelination)(at baseline and 42 months of age)
- Brain function (network topologies)(at baseline and 42 months of age)
- Brain function (connection strengths)(at baseline and 42 months of age)
- Cognitive flexibility(at baseline and 42 months of age)
- Children development(at baseline and 42 months of age)
- School readiness(at 42 months of age)
- Children behavior (for toddlers)(at baseline and 42 months of age)
- Curiosity(at baseline and 42 months of age)
- Sleep quality(at baseline and 42 months of age)
- Home environment(at baseline and 8 months after baseline)
- Feeding practice(at baseline and 42 months of age)
- Fecal microbiota composition(at baseline and 42 months of age)