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Clinical Trials/NCT04660942
NCT04660942
Unknown
Not Applicable

Child Development and Genetic Biomarkers

Chang Gung Memorial Hospital1 site in 1 country446 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Development
Sponsor
Chang Gung Memorial Hospital
Enrollment
446
Locations
1
Primary Endpoint
Scores of cognitive function 1
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
February 28, 2024
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Scores of cognitive function 1

Time Frame: 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)

Time Frame: baseline

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

Scores of cognitive psychological function

Time Frame: baseline

Cantab MOT, PAL, SWM, SOC tests

Scores of motor ability 2

Time Frame: baseline

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

Gene test (WES3)

Time Frame: baseline

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

Gene test (WES4)

Time Frame: 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)

Time Frame: baseline

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

Scores of social behavior 2

Time Frame: baseline

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

Scores of motor ability 1

Time Frame: baseline

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

Gene test (WES2)

Time Frame: baseline

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

Scores of cognitive function 3

Time Frame: baseline

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

Gene test (WES1)

Time Frame: baseline

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

Scores of language function 2

Time Frame: 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

Time Frame: baseline

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

Scores of language function

Time Frame: baseline

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

Scores of general development

Time Frame: baseline

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

Gene test (Mircoarray)

Time Frame: baseline

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

Secondary Outcomes

  • 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)

Study Sites (1)

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