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NCT04955210 Clinical Trial

A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

Critical Illness Clinical Trial

Official title:
Establishment of a Multi-Center Big Data System for Severe Infection and a Collaborative Network on Sepsis in Chinese Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04955210
Other study ID # fdpicu-18
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 30, 2024
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source Children's Hospital of Fudan University
Contact Guoping Lu
Phone 13788904150
Email 13788904150@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. To research the current situation of severe infection in children in China, and to investigate the incidence, prognosis and disease burden of severe infection in children in different regions of China. 2. Establish the risk prediction model and diagnosi model of severe infection in children, and verify the accuracy of the model in multi-center; 3. To study the effectiveness and safety of different treatments in real diagnosis and treatment, and to evaluate the efficacy of subgroups under different ages and high risk factors.

Description:

1.Children between 0 and 18 years old. 2.Severe pneumonia and/or sepsis.Patients were included who meet the guidline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children. 3.notifiable infectious diseases.4.The researcher believes that he is not suitable to participate in other situations in this study.5.Participants in other clinical trials in the same period.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 5000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 29 Days to 18 Years
Eligibility Inclusion Criteria: 1. Children between 0 and 18 years old. 2. Severe pneumonia and/or sepsis. Exclusion Criteria: 1. notifiable infectious diseases. 2. The researcher believes that he is not suitable to participate in other situations in this study. 3. Participants in other clinical trials in the same period.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Not applicable(Cohort study)
This is a prospective observational study and does not include interventions.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Fudan University

Outcome
Type Measure Description Time frame Safety issue
Primary survival rate The survival rate of children in 28 days after their discharged from PICU within 28 days after they discharged from PICU
Secondary length of stay in PICU Time from PICU admission to discharge within 28 days after they discharged from PICU
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