NCT05073549

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 0 Days – 120 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonates

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2021-10-11
• Last updated: 2022-10-25

Locations

26 sites across 1 country: China