Prognosis and Influencing Factors of Asthma in Children Aged 5-12 Years

March 1, 2023 updated by: LI-HONG SUN, Guangzhou Institute of Respiratory Disease
The goal of this observational study is to 1)analyze the basic information of confirmed cases of asthma in children aged 5-12 years old hospitalized in the First Affiliated Hospital of Guangzhou Medical University from 2009 to 2020, 2)investigate the onset of asthma after 13 years old, 3)conducte lung function, blood and airway inflammation indicators, blood IL13 and IL1RL1 levels, 4)analyze the prognosis and influencing factors of children with asthma in this age group.Participants will be asked to fill a case report form and questionnaires. Besides, they should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Research methods:

Part I: Retrospective analysis of hospitalized cases of asthma in children aged 5-12 years old from 2009 to 2020: (1) General information of the children (gender, age and BMI); (2) Special medical history of parents; (3) The history of respiratory virus infection in the early life; (4) that age of the first occurrence of asthma; (5) The number of wheezes in the 12 months before the diagnosis of asthma; (6) Specificity; (7) trigger factors of symptoms; (8) Time pattern of symptom manifestations; (9) Illness severity; (10) Airway inflammation pattern; (11) Baseline of lung function; (12) Anti-inflammatory treatment; (13) Reactions to drug therapy. (14) coinfected diseases or complications. (15) Genetic information.

Part II: Patients who are lost to follow-up will be excluded. The patients will be divided into asthma relief group and asthma continuation group according to whether they had relapsed asthma after 13 years old. The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

Part III: Univariate and multivariate analyses will be performed for different prognostic outcomes of asthma in children aged 5 to 12 years.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the First Affiliated Hospital of Guangzhou Medical University were collected.

Description

Inclusion Criteria:

  • Hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the First Affiliated Hospital of Guangzhou Medical University were collected. Diagnostic criteria were included by referring to global initiative for asthma and Guidelines for Diagnosis, Prevention and Treatment of Pediatric Bronchial Asthma revised in 2008.

Exclusion Criteria:

  • Children who declined follow-up
  • Children with pulmonary and tracheal dysplasia, bronchiolitis obliterans, and other conditions leading to wheezing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Review and collation.
Time Frame: 2022.08-2022.10
To collect the case data of asthma in children aged 5 - 12 and analyze its clinical phenotype.
2022.08-2022.10
Case follow-up
Time Frame: 2022.10-2022.12
The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide specific examination results.
2022.10-2022.12
Data analysis
Time Frame: 2023.1-2023.2
Analyze the data obtained.
2023.1-2023.2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES-2023-005-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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