The Status Quo of Diagnosis and Treatment of Pediatric Outpatients With Respiratory Diseases

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04855604
Collaborator
(none)
10,000
1
9.4
1068

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Retrospective
    Official Title:
    A Cross-sectional Study on the Status Quo of Diagnosis and Treatment of Pediatric Outpatients With Respiratory Diseases in China
    Actual Study Start Date :
    Apr 20, 2021
    Anticipated Primary Completion Date :
    Jan 30, 2022
    Anticipated Study Completion Date :
    Jan 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. General information of pediatric patients [1 year]

      General information of pediatric patients

    Secondary Outcome Measures

    1. History of respiratory diseases and medication of pediatric patients in the past year [1 year]

    2. Diagnosis and medication information of pediatric patients in the Study [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baoping Xu Beijing Beijing China 100045

    Sponsors and Collaborators

    • Beijing Children's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baoping XU, Chief of Respiratory Department Affiliation: Beijing Children's Hospital, Beijing Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04855604
    Other Study ID Numbers:
    • BCH Lung 015
    First Posted:
    Apr 22, 2021
    Last Update Posted:
    Apr 22, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Baoping XU, Chief of Respiratory Department Affiliation: Beijing Children's Hospital, Beijing Children's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2021