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

A Cross-sectional Study on the Status Quo of Diagnosis and Treatment of Pediatric Outpatients With Respiratory Diseases in China

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Diseases

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Recruiting
      • Baoping Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All children aged between 0-14 years, and diagnosed with respiratory disease can be enrolled in our study with their (or their parents') agreements.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General information of pediatric patients	General information of pediatric patients	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
History of respiratory diseases and medication of pediatric patients in the past year	1 year
Diagnosis and medication information of pediatric patients in the Study	1 year

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): January 30, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: treatment; medication; children; respiratory diseases
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: BCH Lung 015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No