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

Recruiting

• Conditions: Critical Illness; Severe Sepsis
• Interventions: Other: Not applicable（Cohort study）

• Registration Number: NCT04955210
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-08
• Study Start: 2022-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe infection	Not applicable（Cohort study）	Children with severe infection in PICU

Primary Outcome Measures

Name	Time	Method
survival rate	within 28 days after they discharged from PICU	The survival rate of children in 28 days after their discharged from PICU

Secondary Outcome Measures

Name	Time	Method
length of stay in PICU	within 28 days after they discharged from PICU	Time from PICU admission to discharge

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China