UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035227 |
|---|---|
| Receipt number | R000040145 |
| Scientific Title | Effects of the Breastfeeding Support for Late Preterm Infant mothers with Educational Program to Nurses: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2019/12/04 11:38:40 |
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Basic information
Public title
Effects of the Breastfeeding Support for Late Preterm Infant mothers with
Educational Program to Nurses: A Randomized Controlled Trial
Acronym
Effects of the Breastfeeding Support for Late Preterm Infant mothers with
Educational Program to Nurses: A Randomized Controlled Trial
Scientific Title
Effects of the Breastfeeding Support for Late Preterm Infant mothers with
Educational Program to Nurses: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of the Breastfeeding Support for Late Preterm Infant mothers with
Educational Program to Nurses: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Late Preterm Infant
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of the Breastfeeding Support for Late Preterm Infant mothers with
Educational Program to Nurses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feeling of self-effect standard score for the mother's milk child care support to mother having LPIs
Social skill standard of the nursing
Key secondary outcomes
The social skill score of the nursing
Knowledge, technical test score necessary for mother's milk child care support to mother having LPIs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Interventions
Effects of the Breastfeeding Support for Late Preterm Infant mothers with
Educational Program to Nurses
One day eight hours
Interventions/Control_2
Control
Non-TechniPretcal Skill Pretrogram
One day eight hours
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
(a) The person who works in the medical office with a perinatal cooperation hospital, a general perinatal medical center, a local perinatal medical center, university hospital, a mother's milk loanword.
(b) Person (having "level III" certification or not does not matter.who can judge that either of "level I, II, III" has an ability for obstetrical practice skill stage (clinical ladder) by oneself Person) that the nurse follows this standard.
(c) The person who can secure a study entry possibility day at the time of a study entry application for two days
(d) A person with the experience that affected mother's milk child care support targeting at the mother and the child of more than 5 latter term premature infants.
Key exclusion criteria
(a) The person who works in facilities carrying out only pregnant woman medical examination in the obstetrics facilities which do not handle delivery, an assistant delivery room.
(b) The managerial class (divisional commander, vice-divisional commander, chief).
(c) The person who plans a leave of absence from duty and the retirement before scheduled educational program enforcement date.
(d) The person who is authorized by international authorized Lactation consultant.
(e) The person with the plan to participate in educational program about mother's milk child care support of LPIs within three months.
(f) The one where I cannot access in a distant place by educational program start time
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi Sato |
Organization
Yokohama City University
Division name
School of Medicine Nursing Course
Zip code
Address
3-9 Fukuura Kanazawa-Ku Yokohama City
TEL
045-787-2548
satoizu3@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi Sato |
Organization
Yokohama City University
Division name
School of Medicine
Zip code
Address
3-9 Fukuura Kanazawa-Ku Yokohama City
TEL
0457872548
Homepage URL
satoizu3@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
The Japan Science and Technology Agency
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
Address
Tel
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
| 2018 | Year | 12 | Month | 12 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040145
