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RecruitingNCT05040542

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

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
3,001 (estimated)
Sponsor
Children's Hospital of Fudan University · Academic / Other
Sex
All
Age
6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERmaternal exposure during pregnancymaternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)

Timeline

Start date
2021-08-01
Primary completion
2026-08-31
Completion
2026-08-31
First posted
2021-09-10
Last updated
2024-11-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05040542. Inclusion in this directory is not an endorsement.