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Child Development and Genetic Biomarkers

Child Development and Genetic Biomarkers

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04660942
Enrollment
446
Registered
2020-12-09
Start date
2020-12-01
Completion date
2024-02-28
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gene test (WES4)baselineWhole-Exome Sequencing (Use Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)
Gene test (Mircoarray)baselineMicroarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)
Gene test (WES1)baselineWhole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85 to screen out the variant discovery and genotyping.)
Gene test (WES2)baselineWhole-Exome Sequencing (Use Samtools86 to screen out the variant discovery and genotyping.)
Gene test (WES3)baselineWhole-Exome Sequencing (Use Picard to screen out the variant discovery and genotyping.)
Scores of cognitive function 1baselineBayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)
Scores of cognitive function (2 y/o to 6 y/o)baselineWechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of cognitive function (6 y/o to 16 y/o)baselineWechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of cognitive function 3baselineTest of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)
Scores of cognitive psychological functionbaselineCantab MOT, PAL, SWM, SOC tests
Scores of language functionbaselinePeabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)
Scores of language function 2baselinePreschool 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 general developmentbaselineComprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)
Scores of social behavior 1baselineClancy Behavior Scale (Scores from 0 to 42, lower scores mean a better outcome.)
Scores of social behavior 2baselineSwanson, Nolan, and Pelham, Version IV (Lower scores mean a better outcome.)
Scores of motor ability 1baselineThe Berry-Buktenica Developmental Test of Visual-Motor Integration (Scores from 0 to 81, Higher scores mean a better outcome.)
Scores of motor ability 2baselineMeasure of Grip and Grasp (Higher scores mean a better outcome.)

Secondary

MeasureTime frameDescription
Scores of participation(>6 y/o)baselineChildren Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)
Scores of activitiesbaselineFunctional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)
Scores of quality of lifebaselinePediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)
Scores of participation(2-5 y/o)baselineAssessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)

Countries

Taiwan

Contacts

Primary ContactChia-Ling Chen, Phd
clingchen@gmail.com+886-3-3281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026