Optimizing Antibiotic Use in Neonatal Intensive Care Units in China

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05073549

Collaborator

China Medical Board (Other)

10,000

Enrollment

Locations

Arm

Anticipated Duration (Months)

384.6

Patients Per Site

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project aims to reduce antibiotic use in Chinese neonatal intensive care units (NICU) by

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.

Condition or Disease	Intervention/Treatment	Phase
Neonates	Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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, vancomycin-resistant Enterococcus, multi-resistant Acinetobacter, multi-resistant Pseudomonas aeruginosa.
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]

Other Outcome Measures

Number of antibiotic courses initiated within 7 days after the discontinuity of the previous course [up to 180 days]
Safety measure which indicate insufficient antibiotic therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 120 Days

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian	China
2	Quanzhou Women and Children's Hospital	Quanzhou	Fujian	China
3	Gansu Provincial Maternity and Child Care Hospital	Lanzhou	Gansu	China
4	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong	China
5	Shenzhen Maternity and Child Health Care Hospital	Shenzhen	Guangdong	China
6	Women and Children's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi	China
7	Guizhou Women and Children's Hospital/Guiyang Children's Hospital	Guiyang	Guizhou	China
8	Henan Children's Hospital	Zhengzhou	Henan	China
9	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
10	Hunan Children's Hospital	Changsha	Hunan	China
11	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
12	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu	China
13	Children's Hospital of Soochow University	Suzhou	Jiangsu	China
14	Suzhou Municipal Hospital affiliated to Nanjing Medical University	Suzhou	Jiangsu	China
15	The First Bethune Hospital of Jilin University	Changchun	Jilin	China
16	General Hospital of Ningxia Medical University	Xining	Ningxia	China
17	Northwest Women's and Children's Hospital	Xi'an	Shaanxi	China
18	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi	China
19	Qingdao Women and Children's Hospital	Qingdao	Shandong	China
20	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China
21	Children' s Hospital of Fudan University	Shanghai	Shanghai	China	201102
22	Children's Hospital of Shanghai	Shanghai	Shanghai	China
23	Tianjin Obstetrics & Gynecology Hospital	Tianjin	Tianjin	China
24	People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang	China
25	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	China
26	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China

Sponsors and Collaborators

Children's Hospital of Fudan University
China Medical Board

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT05073549

Other Study ID Numbers:

2021144

First Posted:

Oct 11, 2021

Last Update Posted:

Oct 22, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 22, 2021