Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neonates

Intervention / Treatment
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* Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative antimicrobial stewardship group<br>Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group. | Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)<br>* 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.<br>|

What is the study measuring?
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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 |