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

NCT04955210 | Recruiting

• 1 other identifier: fdpicu-18
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Severe Sepsis

Keywords

Sepsis; Critical Illness; severe infection

Outcome Measures

Primary Outcomes (1)

• survival rate

  The survival rate of children in 28 days after their discharged from PICU

  within 28 days after they discharged from PICU

Secondary Outcomes (1)

• length of stay in PICU

  within 28 days after they discharged from PICU

Study Arms (1)

Severe infection

Children with severe infection in PICU

Other: Not applicable（Cohort study）

Interventions

Not applicable（Cohort study） OTHER

This is a prospective observational study and does not include interventions.

Severe infection

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children hospitalized in PICU of Children's Hospital of Fudan University from April 2021 to April 2025

You may qualify if:

• Children between 0 and 18 years old.
• Severe pneumonia and/or sepsis.

You may not qualify if:

• notifiable infectious diseases.
• The researcher believes that he is not suitable to participate in other situations in this study.
• Participants in other clinical trials in the same period.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Critical Illness; Sepsis; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Guoping Lu

  The Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoping Lu

CONTACT

13788904150; 13788904150@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: July 8, 2021
• Study Start: April 30, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)