Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Antimicrobial Resistance
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 1200
- Primary Endpoint
- Overall mortality
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
- •Diagnosed with culture-proven sepsis
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall mortality
Time Frame: About 3 months from admission to discharge or death
Incidence of death during the study period
Secondary Outcomes
- Incidence of septic shock(About 3 months from admission to discharge or death)
- Incidence of multiorgan dysfunction(About 3 months from admission to discharge or death)
- Sepsis-related mortality (within 7 days of sepsis)(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)
- Incidence of necrotizing enterocolitis(About 3 months from admission to discharge or death)
- Incidence of meningitis(About 3 months from admission to discharge or death)
- Length of antibiotic treatment(About 3 months from admission to discharge or death)
- Type and quantity of transfusion(About 3 months from admission to discharge or death)
- Incidence of renal failure(About 3 months from admission to discharge or death)
- Incidence of brain injury(About 3 months from admission to discharge or death)
- Length of hospital stay(About 3 months from admission to discharge or death)