The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: maternal exposure during pregnancy.
- Who it may be relevant to
- Registry conditions: Brain Development, Behavior Disorders, Child, Intellectual Developmental Disorders. Basic parameters: up to 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Cohort Study on the Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
Overview
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.
Interventions
- Other maternal exposure during pregnancy
maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)
Primary outcome measures
- Brain structure (cortical thickness) change of subjects [Time frame: at baseline,and 6 months after baseline.]
- Brain structural connectivity change of subjects [Time frame: at baseline,and 6 months after baseline.]
- Brain functional connectivity change of subjects [Time frame: at baseline,and 6 months after baseline.]
- Cerebral blood flow change of subjects [Time frame: at baseline,and 6 months after baseline.]
- EEG examination change of subjects [Time frame: at baseline, and 6 months after baseline.]
- Social and emotional behavior change of subjects (CITSEA score) [Time frame: at baseline,and 6 months after baseline.]
- Brain development change of subjects (GDS score) [Time frame: at baseline,and 6 months after baseline.]
- Developmental level prediction change of subjects (brain age, CITSEA and GDS score) [Time frame: at baseline,and 6 months after baseline.]
- Child behavioral development change of subjects [Time frame: at baseline,and 6 months after baseline.]
- Child mental health change of subjects [Time frame: at baseline, and 6 months after baseline.]
Secondary outcome measures (2)
- Biomarker Screening [Time frame: one time blood draw at baseline.]
- Relationship Assessment between Biomarkers and Development [Time frame: at baseline.]
Eligibility criteria
Inclusion criteria
- Age 0-6 years
- Born at 34-42 weeks of gestation
- Birth weight\>1500g
- Normal brain function assessment
- Parents can understand and sign informed consent
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xiamen Children's Hospital — Xiamen
Publications
- 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
- 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
- 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
- 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 PMID 28592562
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT05040542 · CCBN_01