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
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Critical Illness
• Infections
• Sepsis
• Severe Sepsis
• Toxemia

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