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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04855604
Other study ID # BCH Lung 015
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2021
Est. completion date January 30, 2022

Study information

Verified date April 2021
Source Beijing Children's Hospital
Contact Baoping Xu, MD,PhD
Phone 861059616308
Email xubaopingbch@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A cross-sectional study is expected to conducted by inquiring about the history, diagnosis results and medication details of respiratory diseases of the outpatient pediatric patients with respiratory diseases in the pediatric departments at specialist children's hospital at the second class and above, general hospitals and maternal and child healthcare hospitals. About 10,000 electronic questionnaires are expected to be collected in total, with about 100 participating hospitals and 100 electronic questionnaires from each participating hospital.Diagnosis and treatment information of pediatric patients are expected to be collected in the third week in April, July and October 2021 and in January 2022.


Description:

Respiratory diseases are easy-to-transmit among and are common in children, especially acute respiratory infections in children which contribute to more than 60% of pediatric outpatient cases. In pediatric internal medicine outpatient cases, trachitis/bronchitis, acute upper respiratory tract infection, pneumonia, acute tonsillitis and asthma are the most common diseases torturing pediatric patients. Children are prone to recurrent respiratory infections which may impose heavy burdens on their families. Ten million children under 5 years old are killed by recurrent respiratory infections every year. In China, daily outpatient visits of children with recurrent upper respiratory tract infections account for 10%-20% of the total daily outpatient visits for respiratory diseases. The outpatient medication for pediatric patients is found of non-compliance issues. According to the data in 2014, more than 33.8% of pediatric patients of all ages were given off-label medication, and more than 30% were given off-label medication in treatment. The trial will be completed in 1 years with 10,000 participants taken from hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases, China, and analyze the status quo of diagnosis results and medication details of respiratory diseases of the outpatient pediatric patients with respiratory diseases in China.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date January 30, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 14 Years
Eligibility Inclusion Criteria: - All children participating in this clinical study must meet all of the following criteria. 1. age: 0-14 years old, male and female; 2. accord with diagnostic criteria of respiratory diseases 3. Agreed to informed consent Exclusion Criteria: - All children with any of the following conditions must be excluded from this study: 1. children who visit hospital duo to discharge of hospital 2. Children who visit hospital beyond 2 times in 7 days.

Study Design


Locations

Country Name City State
China Baoping Xu Beijing 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 General information of pediatric patients General information of pediatric patients 1 year
Secondary History of respiratory diseases and medication of pediatric patients in the past year 1 year
Secondary Diagnosis and medication information of pediatric patients in the Study 1 year
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