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NCT Number: NCT04955210

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Severe Sepsis Systemic Inflammatory Response Syndrome

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Guoping Lu, PhD

CONTACT

[email protected]

+86 18017590817

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Not applicable（Cohort study）

Other

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

Primary outcomes

  1. survival rate

    Time frame: within 28 days after they discharged from PICU

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

Secondary outcomes

  1. length of stay in PICU

    Time frame: within 28 days after they discharged from PICU

    Time from PICU admission to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Guoping Lu

CONTACT

[email protected]

13788904150

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2021
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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