Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT05089760
Status:
UNKNOWN
Last Update Posted:
2023-08-31
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China
Sponsor:
Children's Hospital of Fudan University
Organization:
Study Overview
Official Title:
Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: