The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years

Study Overview
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Brief Summary
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This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors in it.To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.

Detailed Description
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This study uses functional magnetic resonance imaging (fMRI) is a ultra-fast imaging technology to reflect the changes in brain function when the brain is stimulated or pathologically affected. There are 4 working imaging techniques for fMRI,including blood-oxygen-level dependent fMRI,perfusion weighted imaging(PWI),perfusion weighted imaging(PWI) and MRI spectroscopy.fMRI combine with cloud computing to analyze brain structure, brain function, brain connection,brain development trajectory,multi-modal brain imaging artificial Intelligent calculation, and draw dynamic connection map of the brain development in children aged 0-6 years.In addition,using the Chinese Urban Children's Emotion and Social Assessment Scale (CITSEA) to evaluate children's social and emotional behavior and Gesell Developmental Scale(GDS) to assess neurological integrity and functional maturity of children, and explore their relationship with brain imaging.Blood samples of enrolled subjects will be taken for the Whole Exon Sequencing to find genes implicated in brain intellectual development, and explore its relationship with brain imaging.This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors in it.To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.

Official Title
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A Cohort Study on the Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years

Conditions
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Brain Development, Behavior Disorders, Child, Intellectual Developmental Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 0-6 years Born at 34-42 weeks of gestation Birth weight>1500g Normal brain function assessment Parents can understand and sign informed consent Exclusion Criteria: The mother had severe complications during pregnancy and delivery History of asphyxiation at birth Have congenital structural malformation Have congenital metabolic disease Have major neuropsychiatric diseases such as craniocerebral injury, craniocerebral tumor, epilepsy, autism, intellectual retardation, schizophrenia, etc. Have major or genetic diseases that affect growth, development or cognition Have contraindications to MRI scanning

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infant Cohort<br>Healthy infants aged from 0-36 months.This is an observational trial so no intervention will be provided, with exception of study assessments, including fMRI. | |
| Preschooler Cohort<br>Healthy preschooler aged from 37-72 months.This is an observational trial so no intervention will be provided, with exception of study assessments, including fMRI. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain structure (cortical thickness) change of subjects | Using T1 weighted and T2 weighted images to measure brain cortical thickness, analyzing the brain structural changes (differences of cortical thickness) over time. | at baseline,and 6 months after baseline. | 
| Brain structural connectivity change of subjects | Using diffusion-weighted images to measure the structural connectivity matrix (based on fiber tracking) of brain, analyzing the brain structural connectivity changes (differences in fibers number) over time. | at baseline,and 6 months after baseline. | 
| Brain functional connectivity change of subjects | Using resting state functional MRI (blood-oxygen-level dependent) to measure the functional connectivity matrix, analyzing the brain functional connectivity (differences in connectivity strength) changes over time. | at baseline,and 6 months after baseline. | 
| Cerebral blood flow change of subjects | Using arterial spin labeling (ASL) to measure relative cerebral blood flow (rCBF) can produce quantitative cerebral perfusion images, analyzing the change (differences in rCBF) of brain perfusion over time. | at baseline,and 6 months after baseline. | 
| Social and emotional behavior change of subjects (CITSEA score) | Using Chinese Version of Urban Infant-Toddler Social and Emotional Assessment (CITSEA) to evaluate children's social and emotional behavior, including four broad domains: 1) externalizing problems; 2) internalizing problems; 3) dysregulation problems; 4) competencies.The problem behavior domain T score >63 is assessed as suspicious positive, indicating possible social-emotional behavior problems; the competencies domain T score <37 is assessed as suspicious positive, indicating there may be a delay in the development of social-emotional ability,analyzing the CITSEA score changes over time. | at baseline,and 6 months after baseline. | 
| Brain development change of subjects (GDS score) | Using Gesell Development Scale (GDS) to assess neurological integrity and functional maturity of children, including adaptive behavior, gross motor behavior, fine motor behavior, language behavior and personal- social behavior.Mild intellectual disability: 55≤DQ≤75;moderate intellectual disability: 40≤DQ≤54;severe mental disability:25≤DQ≤39;extreme intellectual disability: DQ<25, analyzing the GDS score changes over time. | at baseline,and 6 months after baseline. | 
| Developmental level prediction change of subjects (brain age, CITSEA and GDS score) | Using a connectome-based predictive model (CPM) to predict the developmental levels of subjects. In the modal training procedure, extracted multimodal MRI measures (primary outcomes 1 to 4) are input features, and the age, CITSEA and GDS score are ground truths. | at baseline,and 6 months after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic identification of brain intelligence development | The researchers retain children 2ml serum as a sample for the Whole Exon Sequencing to find genes implicated in brain intellectual development. The sequencing results associated with brain imaging characters are used to predict the brain development (minimize the root mean square error of predicted and ground-truth scores of social and emotional behavior), and investigate the contribution of different genes. | one time blood draw at baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm, Newborn, Neonates, Infants, Children, Brain, Development