The Early Life Clinical Feature and Risk Factors Analysis in Children With Neurodevelopmental Disorders

NCT05430256 | Unknown DMC

• 1 other identifier: 201801537A3
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a 5-year retrospective and prospective case control study, included 650 participants, and participants will be divided into four groups.By this research the investigators will achieve several aims:(1) Through the cross-sectional analysis of this study, the investigators can understand the current prevalence of developmental disorders in Taiwan ,especially ADHD and ASD, and the ratio of male to female in school-age children. (2) Analysis of risk factors in preterm infants during pregnancy and infant, and construct the diagnostic predictive models. (3) By the cohort study of premature infants, to analyze early risk factors of premature children with neurological developmental disorders (such as ADHD), and develop the diagnostic predictive models and early interventional tools. (4) Using artificial intelligence and machine learning analysis to analyze the characteristics of preterm and development of diagnostic prediction model of premature infant or premature children combined ADHD. (5) The application of noninvasive physiological signal capture real-time analysis system in screening and evaluation of "premature infant and neurodevelopmental disorders".

Conditions

Premature Infant

Keywords

Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Polysomnography (PSG)

  Change in sleep status based on PSG during the study.

  Once a year until the study is completed(up to 3 years)

• Wechsler Intlligence Scale for Children (WISC)

  Change in speech comprehension, perceptual reasoning, working memory, and processing speed abilities based on WISC during the study. \* This assessment will provide a composite score that represents a child's overall intellectual ability (FSIQ),with higher scores indicating better intellectual ability .

  Once a year until the study is completed(up to 3 years)

Secondary Outcomes (9)

• OSA-18 questionnaire (OSA-18)

  Twice a year until the study is completed(up to 3 years)

• Children's Sleep Habits Questionnaire (CSHQ)

  Twice a year until the study is completed(up to 3 years)

• Disruptive Behaviour Disorder Rating Scale (DBDRS)

  Twice a year until the study is completed(up to 3 years)

• Conners' Continuous Performance Test (CPT)

  Twice a year until the study is completed(up to 3 years)

• Wisconsin Card Sorting Test (WCST)

  Twice a year until the study is completed(up to 3 years)

Study Arms (4)

Premature children with neurological developmental disorder(such as ADHD)

Premature children with neurological developmental disorder (such as ADHD): n = 200

Premature children with neurological developmental disorder(such as ASD)

Premature children with neurological developmental disorder (such as ASD): n = 50

Premature infants with no neurodevelopmental disorders

Premature infants with no neurodevelopmental disorders: n = 200

Age and gender match in non-preterm children

Age and gender match in non-preterm children: n = 200

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

450 premature infants under 37 weeks and 200 non-preterm infants.

You may qualify if:

• The investigators will collect newborns who born in Chang Gung after 2010 .
• The investigators will collect 450 premature infants under 37 weeks and 200 non-preterm infants.
• Participated in the former Ministry of Science and Technology research project ''NSC 101-2314-B-182A-072-MY3'' and project ''106-2314-B-182A-040-MY3'' will be invited to join this study.
• Parents are willing to sign the subject's consent form.

You may not qualify if:

• If children have serious neurological diseases, serious heart problems or serious mental retardation, they will not be able to participate in this study.
• If parents cannot sign the consent form of the subjects.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333423, Taiwan

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Premature Birth; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Yu-Shu Huang, PhD

  Principal Investigator

  STUDY DIRECTOR

Central Study Contacts

Yu-Shu Huang, PhD

CONTACT

+886 3 3281200; yushuhuang1212@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 24, 2022
• Study Start: April 29, 2019
• Primary Completion: October 16, 2022
• Study Completion: January 1, 2024
• Last Updated: June 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)