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

Fudan University

Status: Enrolling

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

Treatments: Other: maternal exposure during pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT05040542

CCBN_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,001 estimated patients

Sex: All

Ages: Under 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 0-6 years
2. Born at 34-42 weeks of gestation
3. Birth weight>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

Trial design

3,001 participants in 1 patient group

Infant Cohort

Description:

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.

Treatment:

Other: maternal exposure during pregnancy