Optimizing Antibiotic Use in Neonatal Intensive Care Units in China
- Conditions
- Neonates
- Interventions
- Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)
- Registration Number
- NCT05073549
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- All infants born at β€31+6 weeks' gestation and admitted to the participating NICUs between October 1st, 2019 and September 30th, 2023.
- The period from October 1st, 2019 to September 30th, 2021 will be used as the baseline period before ASP intervention. Clinical data of eligible infants in this period will be retrospectively collected from a previously established database of preterm infants.
- The ASP implementation will be initiated on October 1st, 2021. The period from October 1st, 2021 to September 31st, 2023 will be the ASP intervention period and data will be prospectively collected.
- Infants who are transferred to non-participating NICUs within 24 hours after birth.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Collaborative antimicrobial stewardship group Collaborative Antimicrobial Stewardship Program (ASP) Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group.
- Primary Outcome Measures
Name Time Method Total antibiotic days of therapy (DOT) per 1000 patient-days up to 180 days DOT is calculated as the sum of days of antibiotics used per patient.
- Secondary Outcome Measures
Name Time Method Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin up to 180 days DOT is calculated as the sum of days of third-generation cephalosporin used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin up to 180 days DOT is calculated as the sum of days of fourth-generation cephalosporin used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam up to 180 days DOT is calculated as the sum of days of piperacillin-tazobactam used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem up to 180 days DOT is calculated as the sum of days of carbapenem used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin up to 180 days DOT is calculated as the sum of days of vancomycin used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid up to 180 days DOT is calculated as the sum of days of linezolid used per patient.
Incidence rate of infections caused by multi-resistant bacteria up to 180 days Multi-resistant bacteria include carbapenem-resistant Enterobacter, methicillin-resistant Staphylococcus aureus \[MRSA\], vancomycin-resistant Enterococcus \[VRE\], multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.
Incidence rate of invasive fungal infections up to 180 days Incidence of mortality up to 180 days Overall mortality and infection-related mortality
Incidences of major morbidities up to 180 days Major morbidities include late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and severe brain injury.
Length of hospital stay up to 180 days
Trial Locations
- Locations (26)
The Affiliated Hospital of Qingdao University
π¨π³Qingdao, Shandong, China
Shaanxi Provincial People's Hospital
π¨π³Xi'an, Shaanxi, China
Children' s Hospital of Fudan University
π¨π³Shanghai, Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University
π¨π³ΓrΓΌmqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
π¨π³Kunming, Yunnan, China
Children's Hospital of Shanghai
π¨π³Shanghai, Shanghai, China
Fujian Maternity and Child Health Hospital
π¨π³Fuzhou, Fujian, China
Quanzhou Women and Children's Hospital
π¨π³Quanzhou, Fujian, China
Gansu Provincial Maternity and Child Care Hospital
π¨π³Lanzhou, Gansu, China
Guangzhou Women and Children's Medical Center
π¨π³Guangzhou, Guangdong, China
Women and Children's Hospital of Guangxi Zhuang Autonomous Region
π¨π³Nanning, Guangxi, China
Henan Children's Hospital
π¨π³Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Nanjing Maternity and Child Health Care Hospital
π¨π³Nanjing, Jiangsu, China
Hunan Children's Hospital
π¨π³Changsha, Hunan, China
Qingdao Women and Children's Hospital
π¨π³Qingdao, Shandong, China
People's Hospital of Xinjiang Uygur Autonomous Region
π¨π³ΓrΓΌmqi, Xinjiang, China
Tianjin Obstetrics & Gynecology Hospital
π¨π³Tianjin, Tianjin, China
Northwest Women's and Children's Hospital
π¨π³Xi'an, Shaanxi, China
Guizhou Women and Children's Hospital/Guiyang Children's Hospital
π¨π³Guiyang, Guizhou, China
Shenzhen Maternity and Child Health Care Hospital
π¨π³Shenzhen, Guangdong, China
Children's Hospital of Nanjing Medical University
π¨π³Nanjing, Jiangsu, China
Suzhou Municipal Hospital affiliated to Nanjing Medical University
π¨π³Suzhou, Jiangsu, China
Children's Hospital of Soochow University
π¨π³Suzhou, Jiangsu, China
General Hospital of Ningxia Medical University
π¨π³Xining, Ningxia, China
The First Bethune Hospital of Jilin University
π¨π³Changchun, Jilin, China