Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China
1 other identifier
observational
1,200
0 countries
N/A
Brief 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). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 31, 2023
August 1, 2023
1 year
September 6, 2021
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall mortality
Incidence of death during the study period
About 3 months from admission to discharge or death
Secondary Outcomes (12)
Sepsis-related mortality (within 7 days of sepsis)
About 3 months from admission to discharge or death
Incidence of multiorgan dysfunction
About 3 months from admission to discharge or death
Incidence of septic shock
About 3 months from admission to discharge or death
Incidence of respiratory failure
About 3 months from admission to discharge or death
Incidence of disseminated intravascular coagulation (DIC)
About 3 months from admission to discharge or death
- +7 more secondary outcomes
Study Arms (1)
Infants with bacteria sepsis
Infants diagnosed with culture-proven sepsis
Interventions
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.
Eligibility Criteria
All neonates diagnosed with culture-proven sepsis and admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
You may qualify if:
- Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
- Diagnosed with culture-proven sepsis
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Fudan Universitylead
- Chinese Neonatal Networkcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun Cao, Ph.D, M.D.
Children's Hospital of Fudan University, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2021
First Posted
October 22, 2021
Study Start
January 1, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
August 31, 2023
Record last verified: 2023-08