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

Brain Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040542
• Other study ID #: CCBN_01
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: Wenhao Zhou, Prof
• Phone: (+86) 021-64931168
• Email: zwhchfu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors in it.To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.

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 map of the 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 neurological integrity and functional maturity of children, and explore their relationship with brain imaging.Blood samples of enrolled subjects will be taken for the Whole Exon Sequencing to find genes implicated in brain intellectual development, and explore its relationship with brain imaging.This study explores the relationship between brain development and infants' social emotion and communication ability, as well as the role of genetic factors in it.To provide a theoretical basis for precise intervention of infants' social emotion and communication problems and the overall improvement of brain development.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1001
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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 neuropsychiatric diseases such as craniocerebral injury, craniocerebral tumor, epilepsy, autism, intellectual retardation, schizophrenia, etc.

6. Have major or genetic diseases that affect growth, development or cognition

7. Have contraindications to MRI scanning

Related Conditions & MeSH terms

• Brain Development
• Child Behavior Disorders
• Developmental Disabilities
• Intellectual Disability
• Mental Disorders

Locations

Country	Name	City	State
China	Xiamen Children's Hospital	Xiamen	Fujian

Sponsors (10)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Changzhou Children's Hospital, Health Science Center of Xi'an Jiaotong University, Nanjing University of Aeronautics and Astronautics, Northwestern Polytechnical University, Shanghai Normal University, Shanghai United Imaging Intelligence Co., Ltd, Shanghai University, ShanghaiTech University, Xiamen Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	Genetic identification of brain intelligence development	The researchers retain children 2ml serum as a sample for the Whole Exon Sequencing to find genes implicated in brain intellectual development. The sequencing results associated with brain imaging characters are used to predict the brain development (minimize the root mean square error of predicted and ground-truth scores of social and emotional behavior), and investigate the contribution of different genes.	one time blood draw at baseline.