UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054656 |
|---|---|
| Receipt number | R000062456 |
| Scientific Title | Assessment of validity and reliability of a novel Neonatal Cardio-Pulmonary Resuscitation Performance Rating Scale in simulation-based education. |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2025/06/17 09:20:42 |
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Basic information
Public title
Assessment of validity and reliability of a novel NCPR performance scale
Acronym
NCPR-PS Study
Scientific Title
Assessment of validity and reliability of a novel Neonatal Cardio-Pulmonary Resuscitation Performance Rating Scale in simulation-based education.
Scientific Title:Acronym
NCPR-PS Study
Region
| Japan |
Condition
Condition
Healthy Healthcare Providers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the validity and reliability of a newly developed neonatal resuscitation (NCPR) performance assessment scale.
Basic objectives2
Others
Basic objectives -Others
Assessment of the validity and reliability of the rating scale.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraclass correlation coefficient
Key secondary outcomes
Criterion validity: correlation between rating scale score and Global rating; correlation between rating scale score and NCPR qualification level 3 classification.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Doctors, midwives and nurses working in neonatal care
Key exclusion criteria
1. those with NCPR I certification (instructor accreditation) who are registered as quality managers (those who supervise instructors)
2. those deemed unsuitable for participation by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Amari |
Organization
Graduate School, The University of Tokyo
Division name
Department of Clinical Information Engineering, School of Public Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3812-2111
cie-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Amari |
Organization
Graduate School, The University of Tokyo
Division name
Department of Clinical Information Engineering, School of Public Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3812-2111
Homepage URL
cie-office@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Shoichiro AMARI
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
[Video of the learners].
An assessment instrument with scenarios on two themes ('Ventilation and technique improvement' and 'Chest compressions and drug administration') is prepared in advance.
The learners are facilitated by a facilitator and work through the scenario exercises using the two scenarios in sequence. In each scenario, learners attempt to resuscitate a neonate by themselves according to the NCPR algorithm (however, a helper is assumed to be present and can give instructions to that imaginary helper, and the facilitator also presents statements and actions as the helper), which are recorded with two video cameras.
[Collecting the results of the assessments by the raters].
Six raters will evaluate the NCPR performance of the research subjects: videos of 30 subjects will be divided into two groups of 15 subjects each, with three raters responsible for the evaluation for each group. The raters receive the videos of the 15 study subjects from the research office via a cloud service (file transfer service) and evaluate NCPR performance using a novel rating scale based on the footage of the two scenario exercises for each subject.
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062456
