Critical IllnessNCT04955210
A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children
An observational study of Critical Illness and Severe Sepsis, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Critical Illness, Severe Sepsis
- What is being tested?
- Not applicable（Cohort study）
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from April 2021 to April 2025
Who may be able to join
- Children between 0 and 18 years old.
- Severe pneumonia and/or sepsis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Guoping Lu, PhD, +86 18017590817, 13788904150@163.com
About this study
Official title: Establishment of a Multi-Center Big Data System for Severe Infection and a Collaborative Network on Sepsis in Chinese Children
- 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.
Read the detailed 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.
- Conditions
- Critical Illness, Severe Sepsis
- Being tested
- Not applicable（Cohort study）
- Keywords
- Sepsis, Critical Illness, severe infection
- Medical subject headings
- Critical Illness, Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable（Cohort study）Other
This is a prospective observational study and does not include interventions.
| Study group | Role | What they receive |
|---|---|---|
| Severe infection | Children with severe infection in PICU Receives: Other: Not applicable（Cohort study） |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
The survival rate of children in 28 days after their discharged from PICU
Measured: within 28 days after they discharged from PICU
Secondary outcomes (1)
length of stay in PICU
Time from PICU admission to discharge
Measured: within 28 days after they discharged from PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start30 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoping Lu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955210
- Sponsor's protocol ID
- fdpicu-18
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Multi-Center Big Data System for Severe Infection and a Collaborative Network on Sepsis in Chinese Children
- ClinicalTrials.gov ID
- NCT04955210
- Acronym / sponsor ID
- fdpicu-18
- Conditions
- Critical Illness, Severe Sepsis
- Keywords
- Sepsis, Critical Illness, severe infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe infection | – | Other: Not applicable（Cohort study）Children with severe infection in PICU |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children hospitalized in PICU of Children's Hospital of Fudan University from April 2021 to April 2025
Key inclusion criteria (2 listed)
- Children between 0 and 18 years old.
- Severe pneumonia and/or sepsis.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable（Cohort study）This is a prospective observational study and does not include interventions. | Other | Severe infection |
Primary outcome
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
1 secondary outcome
length of stay in PICU
Time frame: within 28 days after they discharged from PICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoping Lu principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Severe Sepsis, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoping Lu (13788904150, 13788904150@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: within 28 days after they discharged from PICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.