Clinical trial NCT05073549: Optimizing Antibiotic Use in Neonatal Intensive Care Units in China
Official title: Optimizing Antibiotic Use in Neonatal Intensive Care Units: A Collaborative Antimicrobial Stewardship Program in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonates
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: China Medical Board
First posted: 2021-10-11
Enrollment: 10000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre- and post-study

* 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Infants who are transferred to non-participating NICUs within 24 hours after birth.

Primary outcomes:
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days
timeFrame: up to 180 days
Secondary outcomes:
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin
timeFrame: up to 180 days
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin
timeFrame: up to 180 days
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam
timeFrame: up to 180 days
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem
timeFrame: up to 180 days
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin
timeFrame: up to 180 days
measure: Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid
timeFrame: up to 180 days
measure: Incidence rate of infections caused by multi-resistant bacteria
timeFrame: up to 180 days
measure: Incidence rate of infections caused by multi-resistant bacteria
timeFrame: up to 180 days
measure: Incidence rate of invasive fungal infections
timeFrame: up to 180 days
measure: Incidence of mortality
timeFrame: up to 180 days
measure: Incidences of major morbidities
timeFrame: up to 180 days
measure: Length of hospital stay
timeFrame: up to 180 days
Other outcomes:
measure: Number of antibiotic courses initiated within 7 days after the discontinuity of the previous course
timeFrame: up to 180 days
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou Women and Children's Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Maternity and Child Care Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Maternity and Child Health Care Hospital
state: Guangdong
city: Nanning
country: China
facility: Women and Children's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Women and Children's Hospital/Guiyang Children's Hospital
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Children's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital affiliated to Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Xining
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Northwest Women's and Children's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Qingdao
country: China
facility: Qingdao Women and Children's Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Children' s Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Obstetrics & Gynecology Hospital
state: Tianjin
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References: