The Brain Mechanism of Social Emotion and Communication in Infants Aged 0 to 6 Years
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 0-6 years
Born at 34-42 weeks of gestation
Birth weight>1500g
Normal brain function assessment
Disqualifiers
The mother had severe complications during pregnancy and delivery
History of asphyxiation at birth
Have congenital structural malformation
Have congenital metabolic disease
Trial population
Infants aged 0-6 years are mainly recruited from the society and Xiamen Children\'s Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
maternal exposure during pregnancy
Other interventionmaternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)
Treatment groups
3,001 Participants
are divided into 1 treatment groupGroup A: Infant Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at baseline,and 6 months after baseline.2
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.
Time frame
at baseline,and 6 months after baseline.3
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.
Time frame
at baseline,and 6 months after baseline.4
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.
Time frame
at baseline,and 6 months after baseline.Secondary outcomes
1
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.
Time frame
one time blood draw at baseline.2
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.
Time frame
at baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Xiamen Children's Hospital
Collaborator
ShanghaiTech University
Collaborator
Xi'an Jiaotong University
Collaborator
Shanghai University
Collaborator
Source ClinicalTrials.gov