NCT04660942

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
446

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

November 25, 2020

Last Update Submit

December 14, 2020

Conditions

Child Development

Outcome Measures

Primary Outcomes (17)

  • 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 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 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 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 Outcomes (4)

  • Scores of participation(2-5 y/o)

    baseline

  • Scores of participation(>6 y/o)

    baseline

  • Scores of activities

    baseline

  • Scores of quality of life

    baseline

Study Arms (2)

Control

Healthy child

Experimental

Patients with developmental delay

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age 2-18 y/o
  • Agree to sign informed consent

You may not qualify if:

  • Central nervous system disease
  • Neuromuscular Disorders
  • Congenital Abnormality
  • Genetic Disease
  • Dysesthesia
  • Hearing Impairment
  • Patients with Language Disorder
  • Age 2-18 y/o
  • Agree to sign informed consent
  • Hearing Impairment
  • His or her child participated in this study, and gene abnormality was found.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

Study Officials

  • Chia-Ling Chen, Phd

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen, Phd

CONTACT

+886-3-3281200clingchen@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 9, 2020

Study Start

December 1, 2020

Primary Completion

November 30, 2023

Study Completion

February 28, 2024

Last Updated

December 17, 2020

Record last verified: 2020-11

Locations

TW(1)