UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054611 |
|---|---|
| Receipt number | R000062393 |
| Scientific Title | Practical report on staff education using the Breastfeeding guidelines for infants admitted to NICU |
| Date of disclosure of the study information | 2024/06/08 |
| Last modified on | 2025/06/09 16:34:00 |
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Basic information
Public title
Practical report on staff education using the Breastfeeding guidelines for infants admitted to NICU
Acronym
Practical report on staff education using the Breastfeeding guidelines for infants admitted to NICU
Scientific Title
Practical report on staff education using the Breastfeeding guidelines for infants admitted to NICU
Scientific Title:Acronym
Practical report on staff education using the Breastfeeding guidelines for infants admitted to NICU
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to introduce staff training using the "Guidelines for breastfeeding support for newborns admitted to the NICU" and evaluate whether this was effective in building the foundation of the education system. This is significant in that it will lead to providing higher quality breastfeeding support to mothers and infants admitted to our NICU/GCU.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes will be compared before and after intervention for the support techniques outlined in the 30 key points of breastfeeding support recommended in the guidelines, using a five-point scale of "fully able," "able," "a little able," "hardly able," and "not able at all."
In addition, regarding the goals of breastfeeding support in our department, "The rate of exclusive breastfeeding should be increased," "Breastfeeding should be promoted more even if not exclusive," "Support should be provided according to mothers' wishes," "Staff education on breastfeeding support is sufficient," and "It would be good if there was more information available on breastfeeding support," they were evaluated using a four-point scale of "I agree," "I somewhat agree," "Slightly different," and "I don't agree."
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Staff training will be provided using PowerPoint materials created using the "Breastfeeding Support Guidelines." The training method will consist of three lecture-style study sessions, each lasting about 10 minutes, using the materials, or scenario role-playing based on case studies , conducted during working hours. Staff who are unable to attend will be able to learn knowledge and skills by watching videos of the study sessions.
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
Female
Key inclusion criteria
The pre-intervention survey will involve nursing staff working in the NICU/GCU at Kumamoto University Hospital who are involved in breastfeeding support (34 people).
The post-intervention survey will involve those who took part in the pre-intervention survey.
Key exclusion criteria
Those not directly involved in breastfeeding support (e.g. head nurses, new nurses with less than 3 months experience in this department, etc.) and those who did not give consent to participate in this study.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Iwato |
Organization
Kumamoto University Hospital
Division name
NICU/GCU
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-7044
kao-kumamto@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Iwato |
Organization
Kumamoto University Hospital
Division name
NICU/GCU
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-7044
Homepage URL
kao-kumamto@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Kumamoto University Hospital
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
096-373-7044
kao-kumamto@kuh.kumamoto-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
| 2024 | Year | 06 | Month | 08 | 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
Main results already published
Date of protocol fixation
| 2024 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2024 | Year | 06 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062393
