Brain DevelopmentNCT05040542
The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
An observational study of Brain Development and Behavior Disorders, Child, run by Children's Hospital of Fudan University at 1 site in China.
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 and maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states). Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Development, Behavior Disorders, Child, Intellectual Developmental Disorders
- What is being tested?
- maternal exposure during pregnancy
- How many people
- 3,001 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants aged 0-6 years are mainly recruited from the society and Xiamen Children\'s Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiamen Children's Hospital
Xiamen, Fujian, 361000
Deyi Zhuang, Dean, 15959279526, zhuangdy526@163.com
Xianghui Huang, Director, 13799250830, xmhxh2013@163.com
About this study
Official title: A Cohort Study on the Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
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.
Read the 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.
- Being tested
- maternal exposure during pregnancy
- Keywords
- Preterm, Newborn, Neonates, Infants, Children, Brain, Development
- Medical subject headings
- Child Behavior Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal exposure during pregnancyOther
maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: maternal exposure during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3 years old, 4 years old, 5 years old, and 6 years old.
Secondary outcomes (2)
Biomarker Screening
At enrollment, 0.5 ml of blood was drawn from each parent and child for the exposome. High - throughput sequencing technology will be used to screen for biomarkers associated with brain development.
Measured: one time blood draw at baseline.
Relationship Assessment between Biomarkers and Development
The relationship between the identified biomarkers and children's cognitive and emotional development will be assessed. This will provide a database for understanding the relationship between environment and development, and a scientific basis for future intervention strategies.
Measured: at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Aug 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Brain DevelopmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,001 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Children's Hospital, ShanghaiTech University, Xi'an Jiaotong University, Shanghai University
- Responsible party
- Sponsor
- Investigators
- Deyi Zhuang, Dean, Study chair, Xiamen Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040542
- Sponsor's protocol ID
- CCBN_01
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25596587Cao 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.
PubMed 26941380Cao 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.
PubMed 28684174Emerson 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.
PubMed 28592562Emerson 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.
PubMed 27798142Tavor 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.
PubMed 27124457Zhang 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.
PubMed 27392345Zhang 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.
PubMed 25562829Huang 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.
PubMed 40726941Xu 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.
PubMed 39367488
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
- ClinicalTrials.gov ID
- NCT05040542
- Acronym / sponsor ID
- CCBN_01
- Keywords
- Preterm, Newborn, Neonates, Infants, Children, Brain, Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,001 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Xiamen Children's Hospital, ShanghaiTech University, Xi'an Jiaotong University, Shanghai University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant Cohort | – | Other: maternal exposure during pregnancyHealthy infants aged from 0-72 months.This is an observational trial so no intervention will be provided, with exception of study assessments, including fMRI. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants aged 0-6 years are mainly recruited from the society and Xiamen Children\'s Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maternal exposure during pregnancymaternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states) | Other | Infant Cohort |
Primary outcome
Brain structure (cortical thickness) change of subjects
Time frame: at baseline,and 6 months after baseline.
Using T1 weighted and T2 weighted images to measure brain cortical thickness, analyzing the brain structural changes (differences of cortical thickness) over time.
Brain structural connectivity change of subjects
Time frame: at baseline,and 6 months after baseline.
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.
Brain functional connectivity change of subjects
Time frame: at baseline,and 6 months after baseline.
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.
Cerebral blood flow change of subjects
Time frame: at baseline,and 6 months after baseline.
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.
EEG examination change of subjects
Time frame: at baseline, and 6 months after baseline.
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.
Social and emotional behavior change of subjects (CITSEA score)
Time frame: at baseline,and 6 months after baseline.
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.
Brain development change of subjects (GDS score)
Time frame: at baseline,and 6 months after baseline.
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.
Developmental level prediction change of subjects (brain age, CITSEA and GDS score)
Time frame: at baseline,and 6 months after baseline.
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.
Child behavioral development change of subjects
Time frame: at baseline,and 6 months after baseline.
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.
Child mental health change of subjects
Time frame: at baseline, and 6 months after baseline.
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.
Intelligence quotient change of subjects
Time frame: at 3 years old, 4 years old, 5 years old, and 6 years old.
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.
2 secondary outcomes
Biomarker Screening
Time frame: one time blood draw at baseline.
Relationship Assessment between Biomarkers and Development
Time frame: at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 25596587Ball 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.
- Background: PubMed 26941380Cao 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.
- Background: PubMed 28684174Cao 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.
- Background: PubMed 28592562Emerson 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.
- Background: PubMed 27798142Emerson 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.
- Background: PubMed 27124457Tavor 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.
- Background: PubMed 27392345Zhang 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.
- Background: PubMed 25562829Zhang 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.
- Derived from this study: PubMed 40726941Huang 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.
- Derived from this study: PubMed 39367488Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deyi Zhuang, Dean study chair
Xiamen Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Development and Behavior Disorders, Child, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhao Zhou, Prof ((+86) 021-64931168, zwhchfu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structure (cortical thickness) change of subjects (time frame: at baseline,and 6 months after baseline.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040542, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.