Clinical trial NCT05040542: The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
Official title: A Cohort Study on the Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Development
Behavior Disorders, Child
Intellectual Developmental Disorders
Keywords: Preterm
Newborn
Neonates
Infants
Children
Brain
Development
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Xiamen Children's Hospital
name: ShanghaiTech University
name: Xi'an Jiaotong University
name: Shanghai University
First posted: 2021-09-10
Enrollment: 3001
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged 0-6 years are mainly recruited from the society and Xiamen Children\&#39;s Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 0-6 years
2. Born at 34-42 weeks of gestation
3. Birth weight\&gt;1500g
4. Normal brain function assessment
5. Parents can understand and sign informed consent

Exclusion Criteria:

1. The mother had severe complications during pregnancy and delivery
2. History of asphyxiation at birth
3. Have congenital structural malformation
4. Have congenital metabolic disease
5. Have major or genetic diseases that affect growth, development or cognition
6. Have contraindications to MRI scanning

Primary outcomes:
measure: Brain structure (cortical thickness) change of subjects
timeFrame: at baseline,and 6 months after baseline.
measure: Brain structural connectivity change of subjects
timeFrame: at baseline,and 6 months after baseline.
measure: Brain functional connectivity change of subjects
timeFrame: at baseline,and 6 months after baseline.
measure: Cerebral blood flow change of subjects
timeFrame: at baseline,and 6 months after baseline.
measure: EEG examination change of subjects
timeFrame: at baseline, and 6 months after baseline.
measure: Social and emotional behavior change of subjects (CITSEA score)
timeFrame: at baseline,and 6 months after baseline.
measure: Brain development change of subjects (GDS score)
timeFrame: at baseline,and 6 months after baseline.
measure: Developmental level prediction change of subjects (brain age, CITSEA and GDS score)
timeFrame: at baseline,and 6 months after baseline.
measure: Child behavioral development change of subjects
timeFrame: at baseline,and 6 months after baseline.
measure: Child mental health change of subjects
timeFrame: at baseline, and 6 months after baseline.
measure: Intelligence quotient change of subjects
timeFrame: at 3 years old, 4 years old, 5 years old, and 6 years old.
Secondary outcomes:
measure: Biomarker Screening
timeFrame: one time blood draw at baseline.
measure: Relationship Assessment between Biomarkers and Development
timeFrame: at baseline.
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Children's Hospital
state: Fujian
Study officials:
affiliation: Xiamen Children's Hospital
name: Deyi Zhuang, Dean
role: STUDY_CHAIR
References:
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