- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05800379
Study on Hospitalization of Children With Bronchial Asthma
October 15, 2023 updated by: Kunling Shen, Beijing Children's Hospital
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
470
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: kunling shen, doctor
- Phone Number: +86-010-59616313
- Email: kunlingshen1717@163.com
Study Contact Backup
- Name: ju yin, doctor
- Phone Number: +86-010-59616313
- Email: yinjucw@163.com
Study Locations
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Beijing, China
- Recruiting
- Beijing Children's hospital affiliated to capital medical university
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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
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children admitted with acute episodes of asthma
Description
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
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 |
---|---|---|
Clinical characteristics of hospitalized children with acute asthma attack
Time Frame: From January 2016 to December 2021
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clinical characteristics includes: age, sex, asthma severity (mild, severe), asthma inducing factors(infection, allergy, smoke, excerise) and hospitalization expenses
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From January 2016 to December 2021
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Influencing factors of acute attack severity in hospitalized children with asthma
Time Frame: From January 2016 to December 2021
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age, sex, allergy history, birth history, family history, the severity of asthma exacerbation, lung function and lung computed tomography
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From January 2016 to December 2021
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Risk factors for acute exacerbation of asthma with respiratory failure in children
Time Frame: From January 2016 to December 2021
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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)
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From January 2016 to December 2021
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Risk factors for mucus plug formation in hospitalized children with asthma exacerbation
Time Frame: From January 2016 to December 2021
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The results of lung CT examination in children with asthma(normal, abnormal), the incidence of mucus plug in hospitalized children with asthma
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From January 2016 to December 2021
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Identification of mucus plugs in hospitalized children with asthma
Time Frame: From January 2016 to December 2021
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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.
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From January 2016 to December 2021
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: kunling shen, doctor, Beijing Children's Hospital
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)
July 1, 2023
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
March 1, 2023
First Submitted That Met QC Criteria
March 23, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 15, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCH Lung 010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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