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

NCT05040542 | Recruiting DMC

• 1 other identifier: CCBN_01
• Study Type: observational
• Target: 3,001
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Development; Behavior Disorders, Child; Intellectual Developmental Disorders

Keywords

Preterm; Newborn; Neonates; Infants; Children; Brain; Development

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  at 3 years old, 4 years old, 5 years old, and 6 years old.

Secondary Outcomes (2)

• Biomarker Screening

  one time blood draw at baseline.

• Relationship Assessment between Biomarkers and Development

  at baseline.

Study Arms (1)

Infant Cohort

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

Interventions

maternal exposure during pregnancy OTHER

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

Infant Cohort

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants aged 0-6 years are mainly recruited from the society and Xiamen Children\&#39;s Hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Xiamen Children's Hospital: collaborator
• ShanghaiTech University: collaborator
• Xi'an Jiaotong University: collaborator
• Shanghai University: collaborator

Study Sites (1)

Xiamen Children's Hospital

Xiamen, Fujian, 361000, China

RECRUITING

Related Publications (10)

• Ball G, Pazderova L, Chew A, Tusor N, Merchant N, Arichi T, Allsop JM, Cowan FM, Edwards AD, Counsell SJ. Thalamocortical Connectivity Predicts Cognition in Children Born Preterm. Cereb Cortex. 2015 Nov;25(11):4310-8. doi: 10.1093/cercor/bhu331. Epub 2015 Jan 16.

  PMID: 25596587 BACKGROUND

• Cao M, He Y, Dai Z, Liao X, Jeon T, Ouyang M, Chalak L, Bi Y, Rollins N, Dong Q, Huang H. Early Development of Functional Network Segregation Revealed by Connectomic Analysis of the Preterm Human Brain. Cereb Cortex. 2017 Mar 1;27(3):1949-1963. doi: 10.1093/cercor/bhw038.

  PMID: 26941380 BACKGROUND

• Cao M, Huang H, He Y. Developmental Connectomics from Infancy through Early Childhood. Trends Neurosci. 2017 Aug;40(8):494-506. doi: 10.1016/j.tins.2017.06.003. Epub 2017 Jul 3.

  PMID: 28684174 BACKGROUND

• Emerson RW, Adams C, Nishino T, Hazlett HC, Wolff JJ, Zwaigenbaum L, Constantino JN, Shen MD, Swanson MR, Elison JT, Kandala S, Estes AM, Botteron KN, Collins L, Dager SR, Evans AC, Gerig G, Gu H, McKinstry RC, Paterson S, Schultz RT, Styner M; IBIS Network; Schlaggar BL, Pruett JR Jr, Piven J. Functional neuroimaging of high-risk 6-month-old infants predicts a diagnosis of autism at 24 months of age. Sci Transl Med. 2017 Jun 7;9(393):eaag2882. doi: 10.1126/scitranslmed.aag2882.

  PMID: 28592562 BACKGROUND

• Emerson RW, Gao W, Lin W. Longitudinal Study of the Emerging Functional Connectivity Asymmetry of Primary Language Regions during Infancy. J Neurosci. 2016 Oct 19;36(42):10883-10892. doi: 10.1523/JNEUROSCI.3980-15.2016.

  PMID: 27798142 BACKGROUND

• Tavor I, Parker Jones O, Mars RB, Smith SM, Behrens TE, Jbabdi S. Task-free MRI predicts individual differences in brain activity during task performance. Science. 2016 Apr 8;352(6282):216-20. doi: 10.1126/science.aad8127. Epub 2016 Apr 7.

  PMID: 27124457 BACKGROUND

• Zhang Y, Shi F, Wu G, Wang L, Yap PT, Shen D. Consistent Spatial-Temporal Longitudinal Atlas Construction for Developing Infant Brains. IEEE Trans Med Imaging. 2016 Dec;35(12):2568-2577. doi: 10.1109/TMI.2016.2587628. Epub 2016 Jul 7.

  PMID: 27392345 BACKGROUND

• Zhang W, Li R, Deng H, Wang L, Lin W, Ji S, Shen D. Deep convolutional neural networks for multi-modality isointense infant brain image segmentation. Neuroimage. 2015 Mar;108:214-24. doi: 10.1016/j.neuroimage.2014.12.061. Epub 2015 Jan 3.

  PMID: 25562829 BACKGROUND

• Huang X, Su C, Lin Y, Zhou T, Ye R, Li D, Liu M, Wu G, Li W, Xie N, Deng X, Zhu N, Lin S, Li Q, Yan K, Zhuang D. Cohort protocol: risk assessment of maternal inflammation and early brain development in infants and young children based on multi-source data modeling. Front Public Health. 2025 Jul 14;13:1530285. doi: 10.3389/fpubh.2025.1530285. eCollection 2025.

  PMID: 40726941 DERIVED

• Xu X, Wang Z, Zhang W, Guo J, Wei W, Zhang M, Ding X, Liu X, Yang Q, Wang K, Zhu Y, Sun J, Song H, Shen Z, Chen L, Shi F, Wang Q, Li Y, Zhang H, Li D. Behavioral observation and assessment protocol for language and social-emotional development study in children aged 0-6: the Chinese baby connectome project. BMC Psychol. 2024 Oct 4;12(1):533. doi: 10.1186/s40359-024-02031-x.

  PMID: 39367488 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The researchers retain children 2ml serum as a biological sample for the Whole Exon Sequencing.

MeSH Terms

Conditions

Child Behavior Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Deyi Zhuang, Dean

  Xiamen Children's Hospital

  STUDY CHAIR

Central Study Contacts

Wenhao Zhou, Prof

CONTACT

(+86) 021-64931168; zwhchfu@126.com

Deyi Zhuang, Dean

CONTACT

15959279526; zhuangdy526@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 10, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)