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临床试验/NCT04660942
NCT04660942Unknown不适用

Child Development and Genetic Biomarkers

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 446 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
446
试验地点
1
主要终点
Scores of cognitive function 1

研究概览

简要总结

A study of the relation between genetic biomarkers and child development in Taiwan.

详细描述

The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child development.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Scores of cognitive function 1

时间窗: baseline

Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)

Scores of cognitive function (2 y/o to 6 y/o)

时间窗: baseline

Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)

Scores of cognitive psychological function

时间窗: baseline

Cantab MOT, PAL, SWM, SOC tests

Scores of motor ability 2

时间窗: baseline

Measure of Grip and Grasp (Higher scores mean a better outcome.)

Gene test (WES3)

时间窗: baseline

Whole-Exome Sequencing (Use Picard to screen out the variant discovery and genotyping.)

Gene test (WES4)

时间窗: baseline

Whole-Exome Sequencing (Use Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)

Scores of cognitive function (6 y/o to 16 y/o)

时间窗: baseline

Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)

Scores of social behavior 2

时间窗: baseline

Swanson, Nolan, and Pelham, Version IV (Lower scores mean a better outcome.)

Scores of motor ability 1

时间窗: baseline

The Berry-Buktenica Developmental Test of Visual-Motor Integration (Scores from 0 to 81, Higher scores mean a better outcome.)

Gene test (WES2)

时间窗: baseline

Whole-Exome Sequencing (Use Samtools86 to screen out the variant discovery and genotyping.)

Scores of cognitive function 3

时间窗: baseline

Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)

Gene test (WES1)

时间窗: baseline

Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85 to screen out the variant discovery and genotyping.)

Scores of language function 2

时间窗: baseline

Preschool Language Impaired Scale(PLS)/Language Impaired Scale(LS) (PLS: Scores from 0 to 65, higher scores mean a better outcome. LS: Scores from 0 to 73, higher scores mean a better outcome.)

Scores of social behavior 1

时间窗: baseline

Clancy Behavior Scale (Scores from 0 to 42, lower scores mean a better outcome.)

Scores of language function

时间窗: baseline

Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)

Scores of general development

时间窗: baseline

Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)

Gene test (Mircoarray)

时间窗: baseline

Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)

次要结局

  • Scores of quality of life(baseline)
  • Scores of participation(2-5 y/o)(baseline)
  • Scores of participation(>6 y/o)(baseline)
  • Scores of activities(baseline)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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