NCT06848959

Brief Summary

Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

February 18, 2025

Last Update Submit

February 22, 2025

Conditions

Outcome Measures

Primary Outcomes (14)

  • Childhood Autism Rating Scale

    The total score ranges from 15 to 60, with the higher the score the worse the symptoms are

    4 mouths

  • meridian and acupointological features

    After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".

    4 mouths

  • Yale Global Tic Severity Scale

    It has a score range of 0-100, with higher scores representing more severe symptoms.

    4 mouths

  • Gross Motor Function Assessment Scale (GMFM)-88

    GMFM-88 scores range from 0-264, with higher scores being better.

    4 mouths

  • Autism Behavior Checklist

    It has a score range of 0-174, with higher scores representing more severe symptoms.

    4 mouths

  • acupuncture point status

    After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".

    4 mouths

  • Tongue texture

    After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".

    4 mouths

  • Wechsler intelligence scale (WIS)

    FIQ = 100: Indicates that the individual has an average level of intelligence. FIQ \> 100: Indicates an above average level of intelligence. FIQ \< 100: Indicates a below average level of intelligence.

    4 mouths

  • Resting heart rate

    4 mouths

  • blood pressure (systolic, diastolic) after 10 minutes of rest

    4 mouths

  • Conners Rating Scales

    Scores are converted to standardized T-scores for comparison with the mean of the peer group. T-scores above 65 are usually considered clinically significant.

    4 mouths

  • tongue coating, pulse

    After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".

    4 mouths

  • respiratory rate

    4 mouths

  • Body temperature

    4 mouths

Secondary Outcomes (4)

  • Saliva

    4 mouths

  • blood

    4 mouths

  • Urine

    4 mouths

  • Faeces

    4 mouths

Interventions

Pediatric Encephalopathy Science and Prevention Decision Aid Follow-Up Q\&A

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Childhood encephalopathy

You may qualify if:

  • \. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;

You may not qualify if:

  • \. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;
  • \. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyIntellectual DisabilityAttention Deficit Disorder with HyperactivityAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersChild Development Disorders, Pervasive

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 27, 2025

Study Start

January 1, 2024

Primary Completion

February 28, 2025

Study Completion

December 31, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

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