CClinicalTrials.gg
Status unknownNCT04660942Updated Dec 17, 2020

Child Development and Genetic Biomarkers

An observational study in Child Development, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
446
Ages
1 Year to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Child Development
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
446 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Control

    Healthy child

  • Experimental

    Patients with developmental delay

06

What researchers measure

Primary outcomes

  1. Scores of cognitive function 1

    Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)

    Time frame: baseline

  2. 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.)

    Time frame: baseline

  3. 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.)

    Time frame: baseline

  4. Scores of cognitive function 3

    Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)

    Time frame: baseline

  5. Scores of cognitive psychological function

    Cantab MOT, PAL, SWM, SOC tests

    Time frame: baseline

  6. Scores of language function

    Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)

    Time frame: baseline

  7. 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.)

    Time frame: baseline

  8. Scores of general development

    Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)

    Time frame: baseline

  9. Scores of social behavior 1

    Clancy Behavior Scale (Scores from 0 to 42, lower scores mean a better outcome.)

    Time frame: baseline

  10. Scores of social behavior 2

    Swanson, Nolan, and Pelham, Version IV (Lower scores mean a better outcome.)

    Time frame: baseline

  11. 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.)

    Time frame: baseline

  12. Scores of motor ability 2

    Measure of Grip and Grasp (Higher scores mean a better outcome.)

    Time frame: baseline

  13. Gene test (Mircoarray)

    Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)

    Time frame: baseline

  14. Gene test (WES1)

    Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85 to screen out the variant discovery and genotyping.)

    Time frame: baseline

  15. Gene test (WES2)

    Whole-Exome Sequencing (Use Samtools86 to screen out the variant discovery and genotyping.)

    Time frame: baseline

  16. Gene test (WES3)

    Whole-Exome Sequencing (Use Picard to screen out the variant discovery and genotyping.)

    Time frame: baseline

  17. Gene test (WES4)

    Whole-Exome Sequencing (Use Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)

    Time frame: baseline

Secondary outcomes

  1. Scores of participation(2-5 y/o)

    Assessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)

    Time frame: baseline

  2. Scores of participation(>6 y/o)

    Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)

    Time frame: baseline

  3. Scores of activities

    Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)

    Time frame: baseline

  4. Scores of quality of life

    Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital
    Taoyuan, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04660942
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Dec 9, 2020
Start date
Dec 1, 2020
Primary completion
Nov 30, 2023 (estimated)
Completion
Feb 28, 2024 (estimated)
Last update
Dec 17, 2020

Study contacts

Chia-Ling Chen, Phd
Contact
clingchen@gmail.com
+886-3-3281200 ext. 8148
Chia-Ling Chen, Phd
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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