NeonatesNCT05073549
Optimizing Antibiotic Use in Neonatal Intensive Care Units in China
A study testing Collaborative Antimicrobial Stewardship Program (ASP) in people with Neonates, run by Children's Hospital of Fudan University at 26 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 120 days
- Conditions the study is for
- Neonates
- What is being tested?
- Collaborative Antimicrobial Stewardship Program (ASP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 26 sitesChina
- Study dates
- 1 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Infants who are transferred to non-participating NICUs within 24 hours after birth.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites, 26 recruiting
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
Hui Wu
- Recruiting
Hunan Children's Hospital
Changsha, Hunan
Xirong Gao
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian
Changyi Yang
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
Huayan Zhang
- Recruiting
Guizhou Women and Children's Hospital/Guiyang Children's Hospital
Guiyang, Guizhou
Ling Liu
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Kun Liang
- Recruiting
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, Gansu
Jingyun Shi
- Recruiting
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu
Rui Cheng
- Recruiting
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu
Shuping Han
- Recruiting
Women and Children's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Qiufen Wei
- Recruiting
Qingdao Women and Children's Hospital
Qingdao, Shandong
Ruobing Shan
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Hong Jiang
- Recruiting
Quanzhou Women and Children's Hospital
Quanzhou, Fujian
Dongmei Chen
- Recruiting
Children' s Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Siyuan Jiang, PhD, jiangsiyuan@fudan.edu.cn
- Recruiting
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality
Xiaohui Gong
- Recruiting
Shenzhen Maternity and Child Health Care Hospital
Shenzhen, Guangdong
Chuanzhong Yang
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu
Bin Sun
- Recruiting
Suzhou Municipal Hospital affiliated to Nanjing Medical University
Suzhou, Jiangsu
Zuming Yang
- Recruiting
Tianjin Obstetrics & Gynecology Hospital
Tianjin, Tianjin Municipality
Xiuying Tian
- Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
Long Li
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Mingxia Li
- Recruiting
Northwest Women's and Children's Hospital
Xi'an, Shaanxi
Zhankui Li
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Qin Zhang
- Recruiting
General Hospital of Ningxia Medical University
Xining, Ningxia
Yinpin Qiu
- Recruiting
Henan Children's Hospital
Zhengzhou, Henan
Wenqing Kang
- Recruiting
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Falin Xu
About this study
Official title: Optimizing Antibiotic Use in Neonatal Intensive Care Units: A Collaborative Antimicrobial Stewardship Program in China
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.
Read the 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
- Being tested
- Collaborative Antimicrobial Stewardship Program (ASP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Antimicrobial Stewardship Program (ASP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative antimicrobial stewardship group | Experimental | Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group. Receives: Behavioral: Collaborative Antimicrobial Stewardship Program (ASP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antibiotic days of therapy (DOT) per 1000 patient-days
DOT is calculated as the sum of days of antibiotics used per patient.
Measured: up to 180 days
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 180 days
Incidence rate of invasive fungal infections
Measured: up to 180 days
Incidence of mortality
Overall mortality and infection-related mortality
Measured: 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.
Measured: up to 180 days
Length of hospital stay
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Oct 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073549
- Sponsor's protocol ID
- 2021144
- Status last verified
- Oct 2022
- First submitted
- 6 Sep 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antibiotic Use in Neonatal Intensive Care Units: A Collaborative Antimicrobial Stewardship Program in China
- ClinicalTrials.gov ID
- NCT05073549
- Acronym / sponsor ID
- 2021144
- Conditions
- Neonates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- China Medical Board
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Collaborative antimicrobial stewardship group | Experimental | Behavioral: Collaborative Antimicrobial Stewardship Program (ASP)Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group. |
Who may qualify
- Ages
- 0 to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants who are transferred to non-participating NICUs within 24 hours after birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Collaborative antimicrobial stewardship group |
Primary outcome
Total antibiotic days of therapy (DOT) per 1000 patient-days
Time frame: up to 180 days
DOT is calculated as the sum of days of antibiotics used per patient.
12 secondary outcomes
Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin
Time frame: up to 180 days
Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid
Time frame: up to 180 days
Incidence rate of infections caused by multi-resistant bacteria
Time frame: up to 180 days
Incidence rate of infections caused by multi-resistant bacteria
Time frame: up to 180 days
Incidence rate of invasive fungal infections
Time frame: up to 180 days
Incidence of mortality
Time frame: up to 180 days
Incidences of major morbidities
Time frame: up to 180 days
Length of hospital stay
Time frame: up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Antimicrobial Stewardship Program (ASP) in people with Neonates, run by Children's Hospital of Fudan University at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siyuan Jiang, PhD (8613761644971, jiangsiyuan@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total antibiotic days of therapy (DOT) per 1000 patient-days (time frame: up to 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.