Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China

Not yet recruiting

• Conditions: Antimicrobial Resistance; Neonatal Sepsis
• Interventions: Other: No intervention

• Registration Number: NCT05089760
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Study Start: 2024-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
• Diagnosed with culture-proven sepsis

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with bacteria sepsis	No intervention	Infants diagnosed with culture-proven sepsis

Primary Outcome Measures

Name	Time	Method
Overall mortality	About 3 months from admission to discharge or death	Incidence of death during the study period

Secondary Outcome Measures

Name	Time	Method
Incidence of septic shock	About 3 months from admission to discharge or death	Propertion of infants who occur septic shock
Incidence of multiorgan dysfunction	About 3 months from admission to discharge or death	Propertion of infants who occur multiorgan dysfunction
Sepsis-related mortality (within 7 days of sepsis)	About 3 months from admission to discharge or death	Incidence of death within 7 days after sepsis
Incidence of respiratory failure	About 3 months from admission to discharge or death	Propertion of infants who occur respiratory failure
Incidence of disseminated intravascular coagulation (DIC)	About 3 months from admission to discharge or death	Propertion of infants who occur DIC
Incidence of necrotizing enterocolitis	About 3 months from admission to discharge or death	Propertion of infants who accur necrotizing enterocolitis
Incidence of meningitis	About 3 months from admission to discharge or death	Propertion of infants who accur meningitis
Length of antibiotic treatment	About 3 months from admission to discharge or death	Days of antibiotic treatment
Type and quantity of transfusion	About 3 months from admission to discharge or death	Which kind and how much (ml) of blood product was used during the study
Incidence of renal failure	About 3 months from admission to discharge or death	Propertion of infants who accur renal failure
Incidence of brain injury	About 3 months from admission to discharge or death	Propertion of infants who accur brain injury
Length of hospital stay	About 3 months from admission to discharge or death	Days of hospitalization