Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China

Study Overview
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Brief Summary
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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
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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.

Official Title
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Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units

Conditions
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Antimicrobial Resistance, Neonatal Sepsis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31 Diagnosed with culture-proven sepsis Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with bacteria sepsis<br>Infants diagnosed with culture-proven sepsis | Other: No intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Incidence of death during the study period | About 3 months from admission to discharge or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis-related mortality (within 7 days of sepsis) | Incidence of death within 7 days after sepsis | About 3 months from admission to discharge or death | 
| Incidence of multiorgan dysfunction | Propertion of infants who occur multiorgan dysfunction | About 3 months from admission to discharge or death | 
| Incidence of septic shock | Propertion of infants who occur septic shock | About 3 months from admission to discharge or death | 
| Incidence of respiratory failure | Propertion of infants who occur respiratory failure | About 3 months from admission to discharge or death | 
| Incidence of disseminated intravascular coagulation (DIC) | Propertion of infants who occur DIC | About 3 months from admission to discharge or death | 
| Incidence of renal failure | Propertion of infants who accur renal failure | About 3 months from admission to discharge or death | 
| Incidence of meningitis | Propertion of infants who accur meningitis | About 3 months from admission to discharge or death | 
| Incidence of necrotizing enterocolitis | Propertion of infants who accur necrotizing enterocolitis | About 3 months from admission to discharge or death | 
| Incidence of brain injury | Propertion of infants who accur brain injury | About 3 months from admission to discharge or death | 
| Length of hospital stay | Days of hospitalization | About 3 months from admission to discharge or death | 
| Length of antibiotic treatment | Days of antibiotic treatment | 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 | About 3 months from admission to discharge or death |