An observational study in Brain Development, Behavior Disorders, Child and Intellectual Developmental Disorders, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged Up to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Children's Hospital of Fudan University · Observational
This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors and maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states). To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.
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 maps of 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 the neurological integrity and functional maturity of children, and explore their relationship with brain imaging. The researchers will collect blood samples from the enrollees for whole exome sequencing as well as exposome testing to look for genes related to brain intellectual development and biomarkers related to brain development and to explore their relationship with brain imaging. In addition, the researchers will collect basic information about the family and the mother's health during pregnancy through baseline questionnaires and clinical history data, which will be used to explore pregnancy risk factors for children's brain development and the role of these factors in brain development and the baby's social-emotional and communication skills.
This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors and maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states). To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.
35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.
This study's planned enrollment of 3,001 is above the median of 350 across 10 observational studies indexed under Child Behavior Disorders.
Browse Child Behavior Disorders studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants aged 0-6 years are mainly recruited from the society and Xiamen Children\'s Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy infants aged from 0-72 months.This is an observational trial so no intervention will be provided, with exception of study assessments, including fMRI.
Other: maternal exposure during pregnancy
maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline,and 6 months after baseline.
EEG examination change of subjects
EEG data were collected at each follow-up visit. Electroencephalogram (EEG), especially the event-related potential (ERP) technique, can non-invasively explore the cognitive processes of infant speech recognition, language comprehension, phonological awareness, recognition memory, and facial emotion recognition. The study will collect EEG data from children in resting states, including the power spectral density of different frequency bands (e.g., delta, theta, alpha, beta, gamma), ERP waveform, amplitude, and latency during specific cognitive or sensory tasks, and EEG network connectivity in resting and task states. Through an experimental paradigm designed specifically for different age groups, the influential factors of language and social-emotional development in 0-3 years old infants were explored.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline,and 6 months after baseline.
Child behavioral development change of subjects
Griffiths Development Scales - Chinese Edition (GDSC) : Griffith scale in Chinese children aged 0 \~ 8 speakers of standardized rating scale, with Chinese standard. The scale is divided into two parts, 0-2 years old and 0-8 years old. The 0-2 years old part is composed of 5 fields: The 0-2 years old part is composed of 5 fields, such as "A action ", "B individual-social ", "C language ", "D hand-eye coordination "and "E performance", and the 0-8 years old part adds "F practical reasoning field "on this basis. When the development quotient DQ\<70, development is delayed, and when DQ≥85, development is normal.
Time frame: at baseline,and 6 months after baseline.
Child mental health change of subjects
Ages and Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2) : This scale is used to assess a child's social-emotional development. In general, a higher score means a child needs more attention or is in a higher risk state for social-emotional development.
Time frame: at baseline, and 6 months after baseline.
Intelligence quotient change of subjects
Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) : Use the Chinese version (revised by Professor Zhang Houcan) to assess children's intelligence level. Choose 10 core tests and 4 auxiliary tests from WISC-IV. Four scores, namely the Verbal Comprehension index (VCI), Perceptual Reasoning Index (PRI), Working memory Index (WMI), and processing speed Index (PSI), were calculated from the question bank, and the four composite scores were recombined to form the General Ability Index (GAI) and Cognitive Ability Index (CPI). The resulting total Intelligence quotient (FSIQ). A FSIQ score between 85 and 115 is considered normal intelligence; Between 70 and 84 are classified as borderline intelligence; Less than 70 is classified as low intelligence.
Time frame: at 3 years old, 4 years old, 5 years old, and 6 years old.
Biomarker Screening
At enrollment, 0.5 ml of blood was drawn from each parent and child for the exposome. High - throughput sequencing technology will be used to screen for biomarkers associated with brain development.
Time frame: one time blood draw at baseline.
Relationship Assessment between Biomarkers and Development
The relationship between the identified biomarkers and children's cognitive and emotional development will be assessed. This will provide a database for understanding the relationship between environment and development, and a scientific basis for future intervention strategies.
Time frame: at baseline.
Plan to share: No
Started Aug 2021 (actual). Primary completion is estimated for Aug 2026, 60 months after the start.
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