Optimizing Antibiotic Use in Neonatal Intensive Care Units in China
NCT ID: NCT05073549
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10000 participants
INTERVENTIONAL
2021-10-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
* The period from October 1st, 2019 to September 30th, 2021 will be used as the baseline period before the intervention. Clinical data of eligible infants in this period will be retrospectively collected from a previously established database of preterm infants.
* The intervention will be initiated on October 1st, 2021. The period from October 1st, 2021 to September 31st, 2023 will be the intervention period and data will be prospectively collected.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Collaborative antimicrobial stewardship group
Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group.
Collaborative Antimicrobial Stewardship Program (ASP)
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.
Interventions
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Collaborative Antimicrobial Stewardship Program (ASP)
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
0 Days
120 Days
ALL
No
Sponsors
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China Medical Board
OTHER
Children's Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
Quanzhou Women and Children's Hospital
Quanzhou, Fujian, China
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, Gansu, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Shenzhen Maternity and Child Health Care Hospital
Shenzhen, Guangdong, China
Women and Children's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Guizhou Women and Children's Hospital/Guiyang Children's Hospital
Guiyang, Guizhou, China
Henan Children's Hospital
Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Suzhou Municipal Hospital affiliated to Nanjing Medical University
Suzhou, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Ningxia Medical University
Xining, Ningxia, China
Northwest Women's and Children's Hospital
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Children' s Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Tianjin Obstetrics & Gynecology Hospital
Tianjin, Tianjin Municipality, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Changyi Yang
Role: primary
Dongmei Chen
Role: primary
Jingyun Shi
Role: primary
Huayan Zhang
Role: primary
Chuanzhong Yang
Role: primary
Qiufen Wei
Role: primary
Ling Liu
Role: primary
Wenqing Kang
Role: primary
Falin Xu
Role: primary
Xirong Gao
Role: primary
Rui Cheng
Role: primary
Shuping Han
Role: primary
Bin Sun
Role: primary
Zuming Yang
Role: primary
Hui Wu
Role: primary
Yinpin Qiu
Role: primary
Zhankui Li
Role: primary
Qin Zhang
Role: primary
Ruobing Shan
Role: primary
Hong Jiang
Role: primary
Xiaohui Gong
Role: primary
Xiuying Tian
Role: primary
Long Li
Role: primary
Mingxia Li
Role: primary
Kun Liang
Role: primary
Other Identifiers
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2021144
Identifier Type: -
Identifier Source: org_study_id
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