The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
NCT ID: NCT05040542
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3001 participants
OBSERVATIONAL
2021-08-01
2026-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
maternal exposure during pregnancy
maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)
Interventions
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maternal exposure during pregnancy
maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
ALL
Yes
Sponsors
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Xiamen Children's Hospital
OTHER
ShanghaiTech University
OTHER
Xi'an Jiaotong University
OTHER
Shanghai University
UNKNOWN
Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Deyi Zhuang, Dean
Role: STUDY_CHAIR
Xiamen Children's Hospital
Locations
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Xiamen Children's Hospital
Xiamen, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CCBN_01
Identifier Type: -
Identifier Source: org_study_id
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