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 1	baseline	Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, 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.)
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 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.)
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.)
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.)

Secondary Outcome Measures

Name	Time	Method
Scores of activities	baseline	Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)
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.)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan