Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

Optimizing Antibiotic Use in Neonatal Intensive Care Units: A Collaborative Antimicrobial Stewardship Program in China

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.

Study Overview

• Status: Recruiting
• Conditions: Neonates
• Intervention / Treatment: Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siyuan Jiang, PhD; Phone Number: 8613761644971; Email: jiangsiyuan@fudan.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Maternity and Child Health Hospital
      • Contact: Changyi Yang
    • Quanzhou, Fujian, China
      • Recruiting
      • QuanZhou Women and Children's Hospital
      • Contact: Dongmei Chen
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Gansu Provincial Maternity and Child Care Hospital
      • Contact: Jingyun Shi
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou Women And Children's Medical Center
      • Contact: Huayan Zhang
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Maternity and Child Health Care Hospital
      • Contact: Chuanzhong Yang
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • Women and Children's Hospital of Guangxi Zhuang Autonomous Region
      • Contact: Qiufen Wei
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Guizhou Women and Children's Hospital/Guiyang Children's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Children's Hospital
      • Contact: Wenqing Kang
    • Zhengzhou, Henan, China
      • Recruiting
      • The Third Affiliated Hospital of Zhengzhou University
      • Contact: Falin Xu
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Children's Hospital
      • Contact: Xirong Gao
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Children's Hospital of Nanjing Medical University
      • Contact: Rui Cheng
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Maternity and Child Health Care Hospital
      • Contact: Shuping Han
    • Suzhou, Jiangsu, China
      • Recruiting
      • Children's Hospital of Soochow University
      • Contact: Bin Sun
    • Suzhou, Jiangsu, China
      • Recruiting
      • Suzhou Municipal Hospital affiliated to Nanjing Medical University
      • Contact: Zuming Yang
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Bethune Hospital of Jilin University
      • Contact: Hui Wu
  • Ningxia
    • Xining, Ningxia, China
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Yinpin Qiu
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Northwest Women's and Children's Hospital
      • Contact: Zhankui Li
    • Xi'an, Shaanxi, China
      • Recruiting
      • Shaanxi Provincial People's Hospital
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Hong Jiang
    • Qingdao, Shandong, China
      • Recruiting
      • Qingdao Women and Children's Hospital
      • Contact: Ruobing Shan
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Recruiting
      • Children' s Hospital of Fudan University
      • Contact: Siyuan Jiang, PhD; Email: jiangsiyuan@fudan.edu.cn
    • Shanghai, Shanghai, China
      • Recruiting
      • Children's Hospital of Shanghai
      • Contact: Xiaohui Gong
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Obstetrics & Gynecology Hospital
      • Contact: Xiuying Tian
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
      • Contact: Long Li
    • Ürümqi, Xinjiang, China
      • Recruiting
      • The first affiliated hospital of Xinjiang medical university
      • Contact: Mingxia Li
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
      • Contact: Kun Liang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Collaborative antimicrobial stewardship group; Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: China Medical Board

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 2021144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No