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| Name | Class |
|---|---|
| China Medical Board | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collaborative antimicrobial stewardship group | Experimental | Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative Antimicrobial Stewardship Program (ASP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total antibiotic days of therapy (DOT) per 1000 patient-days | DOT is calculated as the sum of days of antibiotics used per patient. | up to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 180 days |
| Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of antibiotic courses initiated within 7 days after the discontinuity of the previous course | Safety measure which indicate insufficient antibiotic therapy. | up to 180 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siyuan Jiang, PhD | Contact | 8613761644971 | jiangsiyuan@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Maternity and Child Health Hospital | Recruiting | Fuzhou | Fujian | China |
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Pre- and post-study
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DOT is calculated as the sum of days of fourth-generation cephalosporin used per patient. |
| 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. | 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. | 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. | 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. | up to 180 days |
| 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. | 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. | up to 180 days |
| Incidence rate of invasive fungal infections | up to 180 days |
| Incidence of mortality | Overall mortality and infection-related mortality | 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. | up to 180 days |
| Length of hospital stay | up to 180 days |
| Quanzhou Women and Children's Hospital | Recruiting | Quanzhou | Fujian | China |
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| Gansu Provincial Maternity and Child Care Hospital | Recruiting | Lanzhou | Gansu | China |
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| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | China |
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| Shenzhen Maternity and Child Health Care Hospital | Recruiting | Shenzhen | Guangdong | China |
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| Women and Children's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | China |
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| Guizhou Women and Children's Hospital/Guiyang Children's Hospital | Recruiting | Guiyang | Guizhou | China |
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| Henan Children's Hospital | Recruiting | Zhengzhou | Henan | China |
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| The Third Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| Hunan Children's Hospital | Recruiting | Changsha | Hunan | China |
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| Children's Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
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| Nanjing Maternity and Child Health Care Hospital | Recruiting | Nanjing | Jiangsu | China |
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| Children's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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| Suzhou Municipal Hospital affiliated to Nanjing Medical University | Recruiting | Suzhou | Jiangsu | China |
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| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| General Hospital of Ningxia Medical University | Recruiting | Xining | Ningxia | China |
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| Northwest Women's and Children's Hospital | Recruiting | Xi'an | Shaanxi | China |
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| Shaanxi Provincial People's Hospital | Recruiting | Xi'an | Shaanxi | China |
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| Qingdao Women and Children's Hospital | Recruiting | Qingdao | Shandong | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
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| Children' s Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
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| Children's Hospital of Shanghai | Recruiting | Shanghai | Shanghai Municipality | China |
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| Tianjin Obstetrics & Gynecology Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Recruiting | Ürümqi | Xinjiang | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | China |
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| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
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