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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035227
Receipt No. 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 2019/06/14

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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
Email 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
Email satoizu3@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 12 Day
Last follow-up date
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 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040145

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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