This project aims to reduce antibiotic use in Chinese neonatal intensive care units (NICU) by 1) developing an adaptable framework of NICU-targeted antimicrobial stewardship programs (ASP); 2) implementing the NICU-targeted ASP in NICUs using a collaborative quality improvement method; and 3) evaluating the impact of ASP implementation on neonatal antibiotic use.
Antibiotics overuse has been a critical problem in Chinese NICUs associated with the emerging antimicrobial resistance crisis. NICU-targeted ASP have rarely been implemented in Chinese NICUs. Collaborative quality improvement methods have been shown to facilitate clinical practice changes and improve outcomes. In this two-year interventional pre-and post-study, a NICU-targeted ASP will be developed and implemented in Chinese NICUs using the collaborative quality improvement method. The investigators hypothesize that implementing the targeted ASP using a collaborative quality improvement method will reduce the overall antibiotic days of therapy by 20% over a two-year period, comparing the last year of intervention and the last year of baseline period before ASP implementation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
10,000
The collaborative ASP interventions will be implemented from October 1st, 2021 to September 30th, 2023 in all participating NICUs. The collaborative ASP interventions include two levels of interventions that will be delivered at the NICU level: the NICU-targeted ASP program and collaborative quality improvement interventions to facilitate implementation of the ASP. The core elements of the NICU-targeted ASP program include the establishment of ú ASP leader and team, development of the facility-specific antibiotic guidelines, checklist-led audit and feedback, and staff education. The collaborative quality improvement interventions include data feedback and benchmarking, a potential 'better practice' list on neonatal antibiotic use, implementation using Plan-Do-Study-Act cycles and collaborative learning.
Total antibiotic days of therapy (DOT) per 1000 patient-days
DOT is calculated as the sum of days of antibiotics used per patient.
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin
DOT is calculated as the sum of days of third-generation cephalosporin used per patient.
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin
DOT is calculated as the sum of days of fourth-generation cephalosporin used per patient.
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam
DOT is calculated as the sum of days of piperacillin-tazobactam used per patient.
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem
DOT is calculated as the sum of days of carbapenem used per patient.
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin
DOT is calculated as the sum of days of vancomycin used per patient.
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid
DOT is calculated as the sum of days of linezolid used per patient.
Time frame: up to 180 days
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Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
RECRUITINGQuanzhou Women and Children's Hospital
Quanzhou, Fujian, China
RECRUITINGGansu Provincial Maternity and Child Care Hospital
Lanzhou, Gansu, China
RECRUITINGGuangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
RECRUITINGShenzhen Maternity and Child Health Care Hospital
Shenzhen, Guangdong, China
RECRUITINGWomen and Children's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
RECRUITINGGuizhou Women and Children's Hospital/Guiyang Children's Hospital
Guiyang, Guizhou, China
RECRUITINGHenan Children's Hospital
Zhengzhou, Henan, China
RECRUITINGThe Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGHunan Children's Hospital
Changsha, Hunan, China
RECRUITING...and 16 more locations
Incidence rate of infections caused by multi-resistant bacteria
Multi-resistant bacteria include carbapenem-resistant Enterobacter, methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.
Time frame: up to 180 days
Incidence rate of infections caused by multi-resistant bacteria
Multi-resistant bacteria include carbapenem-resistant Enterobacter, methicillin-resistant Staphylococcus aureus \[MRSA\], vancomycin-resistant Enterococcus \[VRE\], multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.
Time frame: up to 180 days
Incidence rate of invasive fungal infections
Time frame: up to 180 days
Incidence of mortality
Overall mortality and infection-related mortality
Time frame: up to 180 days
Incidences of major morbidities
Major morbidities include late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and severe brain injury.
Time frame: up to 180 days
Length of hospital stay
Time frame: up to 180 days