Study on Hospitalization of Children With Bronchial Asthma

Asthma in Children Clinical Trial

Official title:

Study on Hospitalization of Children With Bronchial Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800379
• Other study ID #: BCH Lung 010
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: October 2023
• Source: Beijing Children's Hospital
• Contact: kunling shen, doctor
• Phone: +86-010-59616313
• Email: kunlingshen1717[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Locations

Country	Name	City	State
China	Beijing Children's Hospital affiliated to Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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