Child Development and Genetic Biomarkers

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

Study Overview

• Status: Recruiting
• Conditions: Child Development

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 Type: Observational
• Enrollment (Anticipated): 446

Contacts and Locations

• Study Contact: Name: Chia-Ling Chen, Phd; Phone Number: 8148 +886-3-3281200; Email: clingchen@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy children, children with developmental delay and adults whose children had gene abnormality were recruited.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Healthy child
Experimental; Patients with developmental delay

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Scores of activities	Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)	baseline
Scores of quality of life	Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)	baseline

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): November 30, 2023
• Study Completion (ANTICIPATED): February 28, 2024

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 202001521A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No