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

Sponsor
Guangzhou Institute of Respiratory Disease (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05765383
Collaborator
(none)
400
Enrollment
1
Location
10.9
Anticipated Duration (Months)
36.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prognosis and Influencing Factors of Asthma in Children Aged 5-12 Years
    Actual Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Review and collation. [2022.08-2022.10]

      To collect the case data of asthma in children aged 5 - 12 and analyze its clinical phenotype.

    2. Case follow-up [2022.10-2022.12]

      The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide specific examination results.

    3. Data analysis [2023.1-2023.2]

      Analyze the data obtained.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou institute of respiratory disease Guangzhou Guangdong China 510120

    Sponsors and Collaborators

    • Guangzhou Institute of Respiratory Disease

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LI-HONG SUN, Professor, Guangzhou Institute of Respiratory Disease
    ClinicalTrials.gov Identifier:
    NCT05765383
    Other Study ID Numbers:
    • ES-2023-005-01
    First Posted:
    Mar 13, 2023
    Last Update Posted:
    Mar 13, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LI-HONG SUN, Professor, Guangzhou Institute of Respiratory Disease
    prognosis
    risk factors
    phenotype
    Persistent asthma
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Mar 13, 2023