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

NCT ID: NCT04955210

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Critical Illness Severe Sepsis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe infection

Children with severe infection in PICU

Not applicable(Cohort study)

Intervention Type OTHER

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

Interventions

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Not applicable(Cohort study)

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guoping Lu

Role: PRINCIPAL_INVESTIGATOR

The Children's Hospital of Fudan University

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guoping Lu

Role: CONTACT

13788904150

Facility Contacts

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Guoping Lu, PhD

Role: primary

+86 18017590817

Other Identifiers

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fdpicu-18

Identifier Type: -

Identifier Source: org_study_id

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