Antimicrobial ResistanceNCT05089760
Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China
An observational study of Antimicrobial Resistance and Neonatal Sepsis, run by Children's Hospital of Fudan University.
Trial summary
Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Antimicrobial Resistance, Neonatal Sepsis
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 hour to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: All neonates diagnosed with culture-proven sepsis and admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
Who may be able to join
- Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
- Diagnosed with culture-proven sepsis
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units
Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.
Read the detailed description
All infants with culture-proven sepsis in NICUs of CHNN will be enrolled in the study. Detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. Risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.
- Conditions
- Antimicrobial Resistance, Neonatal Sepsis
- Being tested
- No intervention
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a prospective observational cohort study. The purpose of the study was to compare the incidence of mortality, complications, and other outcomes between infants with multi-resistant bacteria sepsis and infants with sepsis caused by non-multi-resistant bacteria, and compare the incidence of complications and other outcomes between infants with sepsis-related death and infants who survive.
| Study group | Role | What they receive |
|---|---|---|
| Infants with bacteria sepsis | Infants diagnosed with culture-proven sepsis Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Incidence of death during the study period
Measured: About 3 months from admission to discharge or death
Secondary outcomes (12)
Sepsis-related mortality (within 7 days of sepsis)
Incidence of death within 7 days after sepsis
Measured: About 3 months from admission to discharge or death
Incidence of multiorgan dysfunction
Propertion of infants who occur multiorgan dysfunction
Measured: About 3 months from admission to discharge or death
Incidence of septic shock
Propertion of infants who occur septic shock
Measured: About 3 months from admission to discharge or death
Incidence of respiratory failure
Propertion of infants who occur respiratory failure
Measured: About 3 months from admission to discharge or death
Incidence of disseminated intravascular coagulation (DIC)
Propertion of infants who occur DIC
Measured: About 3 months from admission to discharge or death
Incidence of renal failure
Propertion of infants who accur renal failure
Measured: About 3 months from admission to discharge or death
Incidence of meningitis
Propertion of infants who accur meningitis
Measured: About 3 months from admission to discharge or death
Incidence of necrotizing enterocolitis
Propertion of infants who accur necrotizing enterocolitis
Measured: About 3 months from admission to discharge or death
Incidence of brain injury
Propertion of infants who accur brain injury
Measured: About 3 months from admission to discharge or death
Length of hospital stay
Days of hospitalization
Measured: About 3 months from admission to discharge or death
Length of antibiotic treatment
Days of antibiotic treatment
Measured: About 3 months from admission to discharge or death
Type and quantity of transfusion
Which kind and how much (ml) of blood product was used during the study
Measured: About 3 months from admission to discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial ResistanceStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Neonatal Network
- Responsible party
- Sponsor
- Investigators
- Yun Cao, Ph.D, M.D., Principal investigator, Children's Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089760
- Sponsor's protocol ID
- MAROC-ChiNICU
- Status last verified
- Aug 2023
- First submitted
- 6 Sep 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units
- ClinicalTrials.gov ID
- NCT05089760
- Acronym / sponsor ID
- MAROC-ChiNICU
- Conditions
- Antimicrobial Resistance, Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Neonatal Network
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Oct 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.
Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.
Detailed description
All infants with culture-proven sepsis in NICUs of CHNN will be enrolled in the study. Detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. Risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with bacteria sepsis | – | Other: No interventionInfants diagnosed with culture-proven sepsis |
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All neonates diagnosed with culture-proven sepsis and admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
Key inclusion criteria (2 listed)
- Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
- Diagnosed with culture-proven sepsis
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionThis is a prospective observational cohort study. The purpose of the study was to compare the incidence of mortality, complications, and other outcomes between infants with multi-resistant bacteria sepsis and infants with sepsis caused by non-multi-resistant bacteria, and compare the incidence of complications and other outcomes between infants with sepsis-related death and infants who survive. | Other | Infants with bacteria sepsis |
Primary outcome
Overall mortality
Time frame: About 3 months from admission to discharge or death
Incidence of death during the study period
12 secondary outcomes
Sepsis-related mortality (within 7 days of sepsis)
Time frame: About 3 months from admission to discharge or death
Incidence of multiorgan dysfunction
Time frame: About 3 months from admission to discharge or death
Incidence of septic shock
Time frame: About 3 months from admission to discharge or death
Incidence of respiratory failure
Time frame: About 3 months from admission to discharge or death
Incidence of disseminated intravascular coagulation (DIC)
Time frame: About 3 months from admission to discharge or death
Incidence of renal failure
Time frame: About 3 months from admission to discharge or death
Incidence of meningitis
Time frame: About 3 months from admission to discharge or death
Incidence of necrotizing enterocolitis
Time frame: About 3 months from admission to discharge or death
Incidence of brain injury
Time frame: About 3 months from admission to discharge or death
Length of hospital stay
Time frame: About 3 months from admission to discharge or death
Length of antibiotic treatment
Time frame: About 3 months from admission to discharge or death
Type and quantity of transfusion
Time frame: About 3 months from admission to discharge or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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. This study is not recruiting at the moment.
Yun Cao, Ph.D, M.D. principal investigator
Children's Hospital of Fudan University, Shanghai, China
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobial Resistance and Neonatal Sepsis, run by Children's Hospital of Fudan University.
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 1 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Cao, Ph.D. M.D. (+8602164931160, yuncao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality (time frame: About 3 months from admission to discharge or death). 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 31 Aug 2023.