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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое maternal exposure during pregnancy
  maternal exposure during pregnancy (e.g., environmental exposures and maternal inflammatory states)

Первичные конечные точки

• Brain structure (cortical thickness) change of subjects [Срок оценки: at baseline,and 6 months after baseline.]
• Brain structural connectivity change of subjects [Срок оценки: at baseline,and 6 months after baseline.]
• Brain functional connectivity change of subjects [Срок оценки: at baseline,and 6 months after baseline.]
• Cerebral blood flow change of subjects [Срок оценки: at baseline,and 6 months after baseline.]
• EEG examination change of subjects [Срок оценки: at baseline, and 6 months after baseline.]
• Social and emotional behavior change of subjects (CITSEA score) [Срок оценки: at baseline,and 6 months after baseline.]
• Brain development change of subjects (GDS score) [Срок оценки: at baseline,and 6 months after baseline.]
• Developmental level prediction change of subjects (brain age, CITSEA and GDS score) [Срок оценки: at baseline,and 6 months after baseline.]
• Child behavioral development change of subjects [Срок оценки: at baseline,and 6 months after baseline.]
• Child mental health change of subjects [Срок оценки: at baseline, and 6 months after baseline.]

Вторичные конечные точки (2)

• Biomarker Screening [Срок оценки: one time blood draw at baseline.]
• Relationship Assessment between Biomarkers and Development [Срок оценки: at baseline.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Xiamen Children's Hospital — Xiamen

Публикации

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• 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

Идентификаторы

NCT: NCT05040542 · CCBN_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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