Actively Recruiting

Age: 29Days - 18Years
All Genders
ID04955210

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

Led by Children's Hospital of Fudan University · Updated on 2026-03-16

5000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating severe infections, including severe pneumonia and sepsis, in children across different regions of China. The study aims to understand how often these severe infections occur, their outcomes, and the overall burden they place on children. It also seeks to develop and validate risk prediction and diagnosis models for severe infections in children, and to study the effectiveness and safety of various treatments used in real-world clinical practice. This is a prospective observational study involving children from birth up to 18 years old who have severe pneumonia and/or sepsis. The study does not involve any experimental treatments but collects data on children admitted with severe infections in pediatric intensive care units (PICU) across multiple centers in China. Researchers will monitor treatment approaches and evaluate outcomes in different age groups and among those with high-risk factors. Participants will be closely followed during their stay in the PICU and for 28 days after discharge. Researchers will assess survival rates and length of PICU stay as primary and secondary outcomes. The study collects detailed clinical data to build and verify models predicting risk and diagnosis of severe infections. There is no treatment assignment as this is an observational study, and safety, prognosis, and disease burden are carefully monitored throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 29Days - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children between 0 and 18 years old
  • Diagnosis of severe pneumonia and/or sepsis
Not Eligible

You will not qualify if you...

  • Presence of notifiable infectious diseases
  • Investigator believes participant is unsuitable for the study
  • Participation in other clinical trials during the same period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 28 days after discharge from PICU

Participants with severe infection in PICU are observed without any intervention as part of this prospective observational study.

Visits during PICU stay and follow-up until 28 days post-discharge

Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

G

Guoping Lu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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