Study on Hospitalization of Children With Bronchial Asthma

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05800379
Collaborator
(none)
470
24

Study Details

Study Description

Brief Summary

Bronchial asthma is the most common chronic respiratory disease in children. At present, more attention has been paid to the treatment of airway inflammation and smooth muscle spasm, while the related research on the risk factors of asthma attack, mucus plug formation and its effect on asthma has been ignored. This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Children's Asthma Action Plan, family management and medical utilization of children with asthma after discharge.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Asthma is the most common chronic respiratory disease in children. The prevalence of asthma in children in China increased by nearly 50% in 2010 compared with 2000, and the proportion of children hospitalized for asthma exacerbation also increased. China has a large population base, and the number of children with asthma is large. Acute asthma attack is mainly characterized by airway smooth muscle contraction and mucus plug obstruction. At present, more attention has been paid to the treatment of airway mucosal inflammation and smooth muscle spasm, while the related research on the risk factors of asthma acute attack, mucus plug formation and its effect on asthma has been ignored. Bronchoscopy can directly and effectively remove the mucus plug formed in the airway of children with asthma, but there is a lack of clear application standards and procedures. Identifying the risk factors of mucus plug formation in hospitalized children with asthma exacerbation, identifying mucus plug, timely and targeted treatment, and education and training after discharge are of great significance to reduce the hospitalization rate and mortality.This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Children's Asthma Action Plan, family management and medical utilization of children with asthma after discharge.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    470 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Study on Hospitalization of Children With Bronchial Asthma
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Clinical characteristics of hospitalized children with acute asthma attack [From January 2016 to December 2021]

      clinical characteristics includes: age, sex, asthma severity (mild, severe), asthma inducing factors(infection, allergy, smoke, excerise) and hospitalization expenses

    2. Influencing factors of acute attack severity in hospitalized children with asthma [From January 2016 to December 2021]

      age, sex, allergy history, birth history, family history, the severity of asthma exacerbation, lung function and lung computed tomography

    3. Risk factors for acute exacerbation of asthma with respiratory failure in children [From January 2016 to December 2021]

      The proportion of children hospitalized for acute exacerbation of asthma with respiratory failure, and age, sex, allergy history(with or without), family history (asthma, atopic dermatitis,rhinitis and allergy), the severity of asthma exacerbation(mild, severe), lung function (normal, abnormal) and lung computed tomography(normal, abnormal)

    4. Risk factors for mucus plug formation in hospitalized children with asthma exacerbation [From January 2016 to December 2021]

      The results of lung CT examination in children with asthma(normal, abnormal), the incidence of mucus plug in hospitalized children with asthma

    5. Identification of mucus plugs in hospitalized children with asthma [From January 2016 to December 2021]

      Using mucus scoring system which was based on bronchopulmonary segmental anatomy identified mucus plugs in hospitalized children with asthma. Each bronchopulmonary segment was given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe were summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-20.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children admitted with acute episodes of asthma between January 2016 and December 2021

    Exclusion Criteria:
    • Basic information is incomplete

    • Lack of relevant information on diagnosis and treatment after admission

    • Those who disagree with the telephone follow-up

    • Basic diseases such as heart, liver and kidney

    • Children with primary or secondary immunodeficiency, genetic metabolic diseases, tumors, or after organ or hematopoietic stem cell transplantation

    • Active pulmonary tuberculosis and children with a history of asthma who are hospitalized for other reasons

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beijing Children's Hospital

    Investigators

    • Principal Investigator: kunling shen, doctor, Beijing Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kunling Shen, professor, Beijing Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05800379
    Other Study ID Numbers:
    • BCH Lung 010
    First Posted:
    Apr 5, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kunling Shen, professor, Beijing Children's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2023