Child Development and Genetic Biomarkers

Child Development Clinical Trial

Official title:

Child Development and Genetic Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660942
• Other study ID #: 202001521A3
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2020
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Ling Chen, Phd
• Phone: +886-3-3281200
• Email: clingchen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 446
• Est. completion date: February 28, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria of Healthy Child:

• Age 2-18 y/o

• Agree to sign informed consent

Exclusion Criteria of Healthy Child:

• Central nervous system disease

• Neuromuscular Disorders

• Congenital Abnormality

• Genetic Disease

• Dysesthesia

• Hearing Impairment

Inclusion Criteria of Child with developmental delay:

• Patients with Language Disorder

• Age 2-18 y/o

• Agree to sign informed consent

Exclusion Criteria of Child with developmental delay:

• Hearing Impairment

Inclusion Criteria of Adult:

• His or her child participated in this study, and gene abnormality was found.

Related Conditions & MeSH terms

• Child Development

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of cognitive function 1	Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)	baseline
Primary	Scores of cognitive function (2 y/o to 6 y/o)	Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)	baseline
Primary	Scores of cognitive function (6 y/o to 16 y/o)	Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)	baseline
Primary	Scores of cognitive function 3	Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)	baseline
Primary	Scores of cognitive psychological function	Cantab MOT, PAL, SWM, SOC tests	baseline
Primary	Scores of language function	Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)	baseline
Primary	Scores of language function 2	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.)	baseline
Primary	Scores of general development	Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)	baseline
Primary	Scores of social behavior 1	Clancy Behavior Scale (Scores from 0 to 42, lower scores mean a better outcome.)	baseline
Primary	Scores of social behavior 2	Swanson, Nolan, and Pelham, Version IV (Lower scores mean a better outcome.)	baseline
Primary	Scores of motor ability 1	The Berry-Buktenica Developmental Test of Visual-Motor Integration (Scores from 0 to 81, Higher scores mean a better outcome.)	baseline
Primary	Scores of motor ability 2	Measure of Grip and Grasp (Higher scores mean a better outcome.)	baseline
Primary	Gene test (Mircoarray)	Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)	baseline
Primary	Gene test (WES1)	Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85 to screen out the variant discovery and genotyping.)	baseline
Primary	Gene test (WES2)	Whole-Exome Sequencing (Use Samtools86 to screen out the variant discovery and genotyping.)	baseline
Primary	Gene test (WES3)	Whole-Exome Sequencing (Use Picard to screen out the variant discovery and genotyping.)	baseline
Primary	Gene test (WES4)	Whole-Exome Sequencing (Use Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)	baseline
Secondary	Scores of participation(2-5 y/o)	Assessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)	baseline
Secondary	Scores of participation(>6 y/o)	Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)	baseline
Secondary	Scores of activities	Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)	baseline
Secondary	Scores of quality of life	Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)	baseline