Child Development and Genetic Biomarkers

• Conditions: Child Development

• Registration Number: NCT04660942
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study Start: 2020-12-01
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-09
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17
• Primary Completion: 2023-11-30
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scores of cognitive function (2 y/o to 6 y/o)	baseline	Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of cognitive psychological function	baseline	Cantab MOT, PAL, SWM, SOC tests
Scores of motor ability 2	baseline	Measure of Grip and Grasp (Higher scores mean a better outcome.)
Gene test (WES3)	baseline	Whole-Exome Sequencing (Use Picard to screen out the variant discovery and genotyping.)
Gene test (WES4)	baseline	Whole-Exome Sequencing (Use Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)
Scores of cognitive function 3	baseline	Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)
Gene test (WES1)	baseline	Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85 to screen out the variant discovery and genotyping.)
Scores of cognitive function (6 y/o to 16 y/o)	baseline	Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of social behavior 2	baseline	Swanson, Nolan, and Pelham, Version IV (Lower scores mean a better outcome.)
Scores of motor ability 1	baseline	The Berry-Buktenica Developmental Test of Visual-Motor Integration (Scores from 0 to 81, Higher scores mean a better outcome.)
Gene test (WES2)	baseline	Whole-Exome Sequencing (Use Samtools86 to screen out the variant discovery and genotyping.)
Scores of cognitive function 1	baseline	Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)
Scores of language function 2	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	baseline	Clancy Behavior Scale (Scores from 0 to 42, lower scores mean a better outcome.)
Scores of language function	baseline	Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)
Scores of general development	baseline	Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)
Gene test (Mircoarray)	baseline	Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)

Secondary Outcome Measures

Name	Time	Method
Scores of participation(>6 y/o)	baseline	Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)
Scores of quality of life	baseline	Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)
Scores of participation(2-5 y/o)	baseline	Assessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)
Scores of activities	baseline	Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan