Optimizing Antibiotic Use in Neonatal Intensive Care Units in China
1 other identifier
interventional
10,000
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Typical duration for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 25, 2022
October 1, 2022
2 years
September 6, 2021
October 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (12)
Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin
up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin
up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam
up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem
up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin
up to 180 days
- +7 more secondary outcomes
Other Outcomes (1)
Number of antibiotic courses initiated within 7 days after the discontinuity of the previous course
up to 180 days
Study Arms (1)
Collaborative antimicrobial stewardship group
EXPERIMENTALCollaborative antimicrobial stewardship intervention will be implemented in NICUs of this group.
Interventions
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
You may qualify if:
- All infants born at ≤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.
You may not qualify if:
- Infants who are transferred to non-participating NICUs within 24 hours after birth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Fudan Universitylead
- China Medical Boardcollaborator
Study Sites (26)
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, 201102, 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2021
First Posted
October 11, 2021
Study Start
October 1, 2021
Primary Completion
September 30, 2023
Study Completion
December 31, 2023
Last Updated
October 25, 2022
Record last verified: 2022-10