UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059495 |
|---|---|
| Receipt number | R000068052 |
| Scientific Title | Effectiveness of Educational Programs in Enhancing Understanding of Neonatal Resuscitation Algorithms |
| Date of disclosure of the study information | 2025/10/22 |
| Last modified on | 2025/10/21 21:21:24 |
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Basic information
Public title
Effectiveness of Educational Programs in Enhancing Understanding of Neonatal Resuscitation Algorithms
Acronym
Effectiveness of Educational Programs in Enhancing Understanding of Neonatal Resuscitation Algorithms
Scientific Title
Effectiveness of Educational Programs in Enhancing Understanding of Neonatal Resuscitation Algorithms
Scientific Title:Acronym
Effectiveness of Educational Programs in Enhancing Understanding of Neonatal Resuscitation Algorithms
Region
| Japan |
Condition
Condition
Nurse
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Clarify the Effect of Observational Learning on Understanding Neonatal Resuscitation Algorithms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy Rates of Patient Assessment Items and Performed Resuscitation Procedures on the Checklist
Key secondary outcomes
Number of Learning Sessions
Extraction of Correct and Incorrect Items from Checklist Records Based on Video Viewing and Delivery Observation
Extraction of Consistencies and Inconsistencies Identified During Debriefing Sessions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants watch a self-produced video using a manikin. While viewing, they record the assessment items and procedures performed in the video using a checklist. Afterward, they conduct a debriefing session with an NCPR instructor.
Participants attend actual deliveries and observe neonatal resuscitations. Following a checklist, they record the assessment items and procedures performed. A debriefing session is conducted with the NCPR-certified physician who performed the resuscitation. During the study period, participants repeatedly attend deliveries and continue recording assessment items and procedures.
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
| 22 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Certified NCPR Specialist
Certified NCPR Instructor
Key exclusion criteria
Individuals who declined to participate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Kurakata |
Organization
Nihon University Itabashi Hospital
Division name
Nursing Department
Zip code
1738610
Address
30-1, Otayaguchi Kamicho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
kurakata.chie@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Kurakata |
Organization
Nihon University Itabashi Hospital
Division name
Nursing Department
Zip code
1738610
Address
30-1, Otayaguchi Kamicho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
Homepage URL
kurakata.chie@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee, Nihon University Itabashi Hospital,
Address
30-1, Otayaguchi Kamicho, Itabashi-ku, Tokyo, Japan
Tel
0339728111
kurakata.chie@nihon-u.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
| 2025 | Year | 10 | Month | 22 | 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
18
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
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068052
