UMIN-CTR Clinical Trial

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