NCT06327906

Brief Summary

In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Nov 2023

Longer than P75 for all trials

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 Progress41%
Nov 2023Nov 2029

Study Start

First participant enrolled

November 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2029

Last Updated

March 25, 2024

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

March 18, 2024

Last Update Submit

March 18, 2024

Conditions

Child AllergyNeurodevelopmental Disorders

Outcome Measures

Primary Outcomes (2)

  • ASD

    with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis.

    from 2023-11-15 to 2026-11-15

  • ADHD

    with diagnostic criteria of DSM-V ADHD, and SNAP-Ⅳ, CONNER auxiliary diagnosis.

    from 2023-11-15 to 2029-11-15

Eligibility Criteria

Age1 Minute - 42 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The obstetrics department of Qilu Hospital of Shandong University recruit pregnant women. After the delivery of pregnant women, the newborns will included in the cohort.

You may qualify if:

  • ①Allergic questionnaire results were positive.
  • The living area is Jinan City and its surrounding areas in Shandong Province, which is convenient for follow-up.

You may not qualify if:

  • There is a clear diagnosis of brain developmental disorders
  • Psychological diseases
  • History of craniocerebral trauma or brain organic disease ④Major physical diseases ⑤Visual and auditory disorders ⑥ Epilepsy ⑦Intellectual disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Dry blood spots were collected and cryopreserved at -80 °C for gene sequencing.

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • cao aihua, post-doctoral

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

cao aihua, post-doctoral

CONTACT

18560086317xinercah@163.com

zhu mengna, postgraduate

CONTACT

15211482407

Study Design

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

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

November 15, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2029

Last Updated

March 25, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)