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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05504564
Other study ID # 202102436A3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2, 2022
Est. completion date July 31, 2025

Study information

Verified date August 2022
Source Chang Gung Memorial Hospital
Contact Chia-Ling Chen, MD, PhD
Phone +883-3-3281200
Email clingchen@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A study of the relation between genetic biomarkers and child language 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 language development and language disorder.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 8 Years
Eligibility Inclusion Criteria: - Age 2-18 y/o - Agree to sign informed consent Exclusion Criteria: - Central nervous system disease - Neuromuscular Disorders - Congenital Abnormality - Genetic Disease - Dysesthesia - Hearing Impairment Inclusion Criteria of Child with language disorder: - Patients with Language Disorder - Age 2-18 y/o - Agree to sign informed consent - Exclusion Criteria of Child with language disorder: - Hearing Impairment Inclusion Criteria of Adult: - His or her child participated in this study, and gene abnormality was found.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
The experiment does not required any intervention
The experiment does not required any intervention

Locations

Country Name City State
Taiwan Chang Gung Memoria Hospital Taoyuan

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital Ministry of Science and Technology, Taiwan

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 language function 1 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 Gene test 1 Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.) baseline
Primary Gene test 2 Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, 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
See also
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Recruiting NCT04518787 - Genetic Biomarkers Associated With Child Language Development in Taiwan
Completed NCT05510570 - Genetic Biomarkers Associated With Child Language Development in Taiwan (II)