Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

Not Applicable

Recruiting

• Conditions: Neonates

• Registration Number: NCT05073549
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-28
• Study Start: 2021-10-01
• Study First Posted: 2021-10-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total antibiotic days of therapy (DOT) per 1000 patient-days	up to 180 days	DOT is calculated as the sum of days of antibiotics used per patient.

Secondary Outcome Measures

Name	Time	Method
Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin	up to 180 days	DOT is calculated as the sum of days of third-generation cephalosporin used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin	up to 180 days	DOT is calculated as the sum of days of fourth-generation cephalosporin used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam	up to 180 days	DOT is calculated as the sum of days of piperacillin-tazobactam used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem	up to 180 days	DOT is calculated as the sum of days of carbapenem used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin	up to 180 days	DOT is calculated as the sum of days of vancomycin used per patient.
Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid	up to 180 days	DOT is calculated as the sum of days of linezolid used per patient.
Incidence rate of infections caused by multi-resistant bacteria	up to 180 days	Multi-resistant bacteria include carbapenem-resistant Enterobacter, methicillin-resistant Staphylococcus aureus \[MRSA\], vancomycin-resistant Enterococcus \[VRE\], multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.
Incidence rate of invasive fungal infections	up to 180 days
Incidence of mortality	up to 180 days	Overall mortality and infection-related mortality
Incidences of major morbidities	up to 180 days	Major morbidities include late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and severe brain injury.
Length of hospital stay	up to 180 days

Trial Locations

Locations (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

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