Actively Recruiting

Age: 0 - 6Years
All Genders
Healthy Volunteers
ID05040542

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

Led by Children's Hospital of Fudan University ยท Updated on 2024-11-19

3001

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Children's Hospital of Fudan University

Lead Sponsor

X

Xiamen Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how brain development in infants up to 6 years old relates to their social emotions and communication skills. The study also examines the influence of genetic factors and maternal exposures during pregnancy, such as environmental factors and maternal inflammatory conditions. The goal is to provide a foundation for targeted interventions to improve infants' social and emotional abilities and overall brain development. The study uses advanced brain imaging techniques, including functional magnetic resonance imaging (fMRI) with multiple methods like blood-oxygen-level dependent imaging and perfusion weighted imaging. These imaging methods, combined with cloud-based analysis and artificial intelligence, help map brain structure, function, connectivity, and development trajectories. Researchers also assess children's social-emotional behavior using the Chinese Urban Children's Emotion and Social Assessment Scale and neurological development with the Gesell Developmental Scale. Blood samples are collected for genetic and biomarker analysis, and family and maternal health information during pregnancy is gathered through questionnaires and clinical history. Participants will undergo brain scans and assessments at the start of the study and again six months later, with intelligence quotient measured annually from ages 3 to 6. Researchers will monitor changes in brain structure, function, blood flow, EEG, social-emotional behavior, brain development, and child mental health. Biomarker screening occurs once at baseline. The study spans from infancy through early childhood, with data collected to understand brain development changes and predict developmental outcomes over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0 to 6 years
  • Born between 34 and 42 weeks of gestation
  • Birth weight greater than 1500 grams
  • Normal brain function assessment
  • Parents able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Mother had severe complications during pregnancy and delivery
  • History of asphyxiation at birth
  • Presence of congenital structural malformation
  • Presence of congenital metabolic disease
  • Major or genetic diseases affecting growth, development, or cognition
  • Contraindications to MRI scanning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline and 6 months after baseline

Participants undergo brain imaging and assessments including fMRI scans, EEG examinations, blood draws for biomarker screening, and developmental behavior evaluations to explore brain development and social-emotional communication.

2 visits (in-person) at baseline and 6 months

Long-term Monitoring

Duration - Up to 6 years

Participants are followed to monitor brain development and intelligence quotient changes through periodic assessments at ages 3, 4, 5, and 6 years.

4 visits (in-person) annually at ages 3 to 6

Trial Site Locations

Total: 1 location

1

Xiamen Children's Hospital

Xiamen, Fujian, China, 361000

Actively Recruiting

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Research Team

W

Wenhao Zhou, Prof

D

Deyi Zhuang, Dean

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Cohort protocol: risk assessment of maternal inflammation and early brain development in infants and young children based on multi-source data modeling.

Xianghui Huang, Cuimin Su, Ying Lin...

https://pubmed.ncbi.nlm.nih.gov/40726941

Behavioral observation and assessment protocol for language and social-emotional development study in children aged 0-6: the Chinese baby connectome project.

Xinpei Xu, Zhixin Wang, Weijia Zhang...

https://pubmed.ncbi.nlm.nih.gov/39367488