UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050682 |
|---|---|
| Receipt number | R000057744 |
| Scientific Title | Investigation and utilization of predictive factors to prevent outbreaks of MRSA in NICU -Focusing on Environmental Factors (Secondary Research) |
| Date of disclosure of the study information | 2023/03/28 |
| Last modified on | 2024/09/27 19:18:34 |
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Basic information
Public title
Investigation and utilization of predictive factors to prevent outbreaks caused by methicillin-resistant Staphylococcus aureus in neonatal intensive care units -Focusing on Environmental Factors (Secondary Research)
Acronym
Investigation and utilization of predictive factors to prevent outbreaks caused by methicillin-resistant Staphylococcus aureus in neonatal intensive care units -Focusing on Environmental Factors (Secondary Research)
Scientific Title
Investigation and utilization of predictive factors to prevent outbreaks of MRSA in NICU
-Focusing on Environmental Factors (Secondary Research)
Scientific Title:Acronym
Investigation and utilization of predictive factors to prevent outbreaks of MRSA in NICU
-Focusing on Environmental Factors (Secondary Research)
Region
| Japan |
Condition
Condition
methicillin-resistant staphylococcus aureus
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct surveillance (intervention studies) using the MRSA Outbreak Forecast Sheet (hereinafter referred to as the sheet) and evaluate the sheet
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRSA new incidence rate(After one month of surveillance)
Key secondary outcomes
State characteristics anxiety results for nurses with less than five years of NICU experience
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
MRSA outbreak forecast sheets will be used in the intervention group during the surveillance period(Intervention period is one month).
Interventions/Control_2
The control group will be monitored for one month using their own indicators.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurses working in the NICU will be targeted.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Hatakeyama |
Organization
University of Human Enviroments
Division name
Graduate School of Nursing
Zip code
474-0035
Address
Ebata cho, Obu City, Aichi Prefecture
TEL
0562-43-0701
dn19002@uhe.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhito |
| Middle name | |
| Last name | Hatakeyama |
Organization
University of Human Enviroments
Division name
Graduate School of Nursing
Zip code
474-0035
Address
Ebata cho, Obu City, Aichi Prefecture
TEL
0562-43-0701
Homepage URL
dn19002@uhe.ac.jp
Sponsor or person
Institute
University of Human Enviroments
Institute
Department
Personal name
Kazuhito Hatakeyama
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Human Enviroments
Address
Ebata cho, Obu City, Aichi Prefecture
Tel
0562-43-0701
h-sasaki@uhe.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
https://uhe.repo.nii.ac.jp/records/2000105
Publication of results
Partially published
Result
URL related to results and publications
https://uhe.repo.nii.ac.jp/?page=1&size=20&sort=createdate&search_type=0&q=0
Number of participants that the trial has enrolled
40
Results
The average MRSA incidence rate in the six facilities in the intervention group after using Kazu sheet-X was 1.36, which was significantly lower than the MRSA incidence rate at all times (p=0.035).
Results date posted
| 2024 | Year | 09 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
nurse
Participant flow
The intervention group was evaluated using Kazu sheet-X, and the control group was evaluated using individual existing methods. With Kazu sheet-X, night shift work conditions and MRSA carriage rates were evaluated every day, and depending on the evaluation results, a three-stage classification was performed, and infection control measures were implemented according to the evaluation results. The survey using Kazu sheet-X was conducted from January 1, 2023 to July 31, 2023. The study started at 13 NICUs nationwide (7 facilities in the intervention group and 6 facilities in the control group), but one facility in the intervention group withdrew midway through the study, resulting in 6 facilities in both groups, for a total of 12 facilities.
The responses to the questionnaire were: 6 head nurses in the intervention group (response rate 85.7%), night shift leader nurses: 30 (response rate 85.7%), nurses with less than 5 years of NICU experience: 40 (response rate 88.9%) The control group consisted of 6 head nurses (100% response rate) and 35 nurses with less than 5 years of NICU experience (100% response rate).
Adverse events
none
Outcome measures
MRSA carriage rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057744
