NCT05800379

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

March 1, 2023

Last Update Submit

October 15, 2023

Conditions

Keywords

asthmachildrenmucus plugFlexible bronchoscope

Outcome Measures

Primary Outcomes (5)

  • Clinical characteristics of hospitalized children with acute asthma attack

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

    From January 2016 to December 2021

  • Influencing factors of acute attack severity in hospitalized children with asthma

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

    From January 2016 to December 2021

  • Risk factors for acute exacerbation of asthma with respiratory failure in children

    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)

    From January 2016 to December 2021

  • Risk factors for mucus plug formation in hospitalized children with asthma exacerbation

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

    From January 2016 to December 2021

  • Identification of mucus plugs in hospitalized children with asthma

    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.

    From January 2016 to December 2021

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children admitted with acute episodes of asthma

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital affiliated to Capital Medical University

Beijing, China

RECRUITING

Related Publications (1)

  • Han P, Yin J, Zou H, Jiao A, Liu Y, Shen K. Exploring the types of airway inflammation in hospitalized children with asthma. BMC Pediatr. 2025 May 7;25(1):359. doi: 10.1186/s12887-025-05596-7.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • kunling shen, doctor

    Beijing Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kunling shen, doctor

CONTACT

ju yin, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 5, 2023

Study Start

July 1, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations