Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diffusivity
研究概览
简要总结
The unique importance of human brain development during the first years of life is unquestionable. During an infant's first year, the brain undergoes its most dramatic structural and functional changes, with factors such as early social experience having a significant effect on this development. This study proposes to investigate changes in both brain and behavior across the first 12 months of life. At three time points (~3, 6, and 12 month), anatomical and diffusion magnetic resonance imaging (MRI), resting state functional magnetic resonance imaging (fMRI), electroencephalography (EEG), eye tracking, and observational data will be obtained from the same sample of infants. These measures will be used to track the development of important sensorimotor, socio-emotional, and cognitive skills and their underlying neural correlates, as well as investigate the effects of early social experience on specific aspects of this development
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborns, boys and girls, aged 3 months
- •Uncomplicated pregnancy and delivery, APGAR scores >8
- •Full-term birth without identified neuromotor problems at birth
- •No congenital or developmental anomalies affecting the brain
- •No reported history of neurological disorders or learning disabilities in the infants
- •No reported specific visual, developmental and cognitive impairment
- •Absence of medication having a cerebral or psychological impact
- •Both parents/ legal guardian must provide their consent and signature prior to participation of their infant in the study
排除标准
- •Severe congenital malformation
- •Infants requiring a corrective surgery
- •Any refusal of a parent
- •Infants with severe impairment of the general condition and vital functions
- •Infants with dermatitis of the face or scalp
- •Infants who receive neurological treatment
- •Infants born pre-term (birth before 37 weeks gestation)
- •Infants whose mothers have significant medical conditions and/or had significant complications during pregnancy
- •Infants who are adopted,
- •Infants who have a first degree relative with autism, intellectual disability, schizophrenia, or bipolar disorder,
- •Infants who have any significant medical and/or genetic conditions affecting growth, development, or cognition,
- •Infants who have any contraindication to MRI (metallic object, surgical material like cochlear implant)
- •Maternal pre- eclampsia, placental abruption, maternal HIV status, and maternal alcohol or illicit drug use during pregnancy.
研究组 & 干预措施
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: MRI/DTI (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: EEG (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: Eye Tracking (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: Ages and Stages Questionnaire (ASQ) (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: Infant Behavior Questionnaire Revised (IBQ-R) (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: Beck Depression Inventory (BDI) (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: The Brief Fear of Negative Evaluation Scale (BFNE) (Other)
Infants aged around 3 month
80 infants aged around 3 months will be included in this study up to around 12.5 months
干预措施: Edinburgh Postnatal Depression Scale (Other)
结局指标
主要结局
Diffusivity
时间窗: 9 months following the inclusion
Integrity of white matter fiber tracts assessed by DTI measures of the mean, radial, and axial diffusivity (mm2/s) along them.
Regional myelination
时间窗: 9 months following the inclusion
Regional myelination assessed by T1 / T2 intensity ratios.
Fractional anisotropy
时间窗: 9 months following the inclusion
Integrity of white matter fiber tracts assessed by DTI measures of the mean fractional anisotropy (0-1, where 0=isotropic diffusion, 1=diffusion restricted along one dimension) along them.
次要结局
- Motor beta burst timing(9 months following the inclusion)
- Infant Behavioral Questionnaire Revised score(9 months following the inclusion)
- Brief Fear of Negative Evaluation total score(9 months following the inclusion)
- Edinburgh Postnatal Depression Scale total score(9 months following the inclusion)
- Motor beta burst peak frequency(9 months following the inclusion)
- Infant eye movement attentional bias(9 months following the inclusion)
- Ages and Stages Questionnaire scores(9 months following the inclusion)