Child AllergyNCT06327906
A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
An observational study of Child Allergy and Neurodevelopmental Disorders, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 42 days
- Conditions the study is for
- Child Allergy, Neurodevelopmental Disorders
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 15 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 42 days
- All sexes
- Child
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.
Who may be able to join
- ①Allergic questionnaire results were positive.
- The living area is Jinan City and its surrounding areas in Shandong Province, which is convenient for follow-up.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
zhu mengna, postgraduate contact
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
zhu mengna, 15211482407
About this study
Official title: A Series of Studies Based on a Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
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.
Read the detailed description
In this study, a birth cohort was established, and infants were divided into two groups according to inclusion and exclusion criteria ( see study design ). One group was allergic group, and the other group was control group. The two groups will be followed up for up to 6 years, and specimens ( blood, urine, feces ) and test data ( height, weight, GESELL, etc. ) will be retained during the follow-up period. The outcome indicators were ASD, ADHD or LD, and DSM-5 was used as the diagnostic criteria.
- Conditions
- Child Allergy, Neurodevelopmental Disorders
- Medical subject headings
- Neurodevelopmental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
ASD
with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis.
Measured: from 2023-11-15 to 2026-11-15
ADHD
with diagnostic criteria of DSM-V ADHD, and SNAP-Ⅳ, CONNER auxiliary diagnosis.
Measured: from 2023-11-15 to 2029-11-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Nov 2023
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AllergyStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cao aihua, post-doctoral, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327906
- Sponsor's protocol ID
- qilu000002
- Status last verified
- Oct 2023
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Series of Studies Based on a Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China
- ClinicalTrials.gov ID
- NCT06327906
- Acronym / sponsor ID
- qilu000002
- Conditions
- Child Allergy, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, a birth cohort was established, and infants were divided into two groups according to inclusion and exclusion criteria ( see study design ). One group was allergic group, and the other group was control group. The two groups will be followed up for up to 6 years, and specimens ( blood, urine, feces ) and test data ( height, weight, GESELL, etc. ) will be retained during the follow-up period. The outcome indicators were ASD, ADHD or LD, and DSM-5 was used as the diagnostic criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 42 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- ①Allergic questionnaire results were positive.
Key exclusion criteria (3 listed)
- There is a clear diagnosis of brain developmental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ASD
Time frame: from 2023-11-15 to 2026-11-15
with diagnostic criteria of DSM-V ASD, and ADOS, CARS auxiliary diagnosis.
ADHD
Time frame: from 2023-11-15 to 2029-11-15
with diagnostic criteria of DSM-V ADHD, and SNAP-Ⅳ, CONNER auxiliary diagnosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
zhu mengna, postgraduate contact
cao aihua, post-doctoral principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Allergy and Neurodevelopmental Disorders, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cao aihua, post-doctoral (18560086317, xinercah@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASD (time frame: from 2023-11-15 to 2026-11-15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.