Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

Fudan University

Status: Enrolling

Conditions: Neonates

Treatments: Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05073549

2021144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: Under 120 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

Collaborative antimicrobial stewardship group

Experimental group

Description:

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

Treatment:

Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)