UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Acronym	Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Scientific Title	Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Scientific Title:Acronym	Evaluation of Educational Program for Nurses Focusing on Early Essential Care Related to Milk Expression for Mothers of Preterm Infants
Region	Japan

Condition
Condition	Premature delivery
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of educational program for nurses focusing on early essential care related to milk expression for mothers of preterm infants. Evaluation of this educational program by nurses is also included.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nurses' knowledge about care related to breast milk expression (three months prior to the educational program, just before the educational program, just after the educational program, three months after the educational program)
Key secondary outcomes	Nurses' attitude about care related to breast milk expression (three months before the educational program, just before the educational program, just after the educational program, three months after the educational program), Nurses' status of implementation of care (three months before the educational program, just before the educational program, three months after the educational program), Mothers' amount of breast milk (on the fourth day and on the tenth day after delivery), Timing of initiation of breast milk expression, Number of times of breast milk expression (for 10 days after delivery), Mothers' perception of nurses' care related to breast milk expression (after discharge), Nurses' evaluation of educational program (three months after the educational program)

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	Behavior,custom
Interventions/Control_1	Carry out the educational program for nurses focusing on early essential care related to breast milk expression for mothers of preterm infants in 60 minutes. The follow-up is also included three months after the educational program.
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	Male and Female
Key inclusion criteria	34 nurses and midwives who are working in the maternity ward in a perinatal medical center and providing care for mothers of preterm infants (16 mothers who are delivering an infant with a gestational age of less than 35 weeks in the hospital where nurses who participate in this study are working, expressing breast milk to breastfeed their own baby, and being admitted to the maternity ward)
Key exclusion criteria	Nurses and midwives who are not applicable to key inclusion criteria (Mothers who did not recover enough after confinement, or mothers whose infants were in serious condition)
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Rie Middle name Last name Tanaka
Organization	St. Luke's International University
Division name	Graduate School of Nursing Science
Zip code	1040044
Address	10-1, Akashi-cho, Chuo-ku, Tokyo
TEL	03-3543-6391
Email	16dn011@slcn.ac.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Tanaka
Organization	St. Luke's International University
Division name	Graduate School of Nursing Science
Zip code	1040044
Address	10-1, Akashi-cho, Chuo-ku, Tokyo
TEL	03-3543-6391
Homepage URL
Email	16dn011@slcn.ac.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

Funding Source
Organization	Teikyo University
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	Research Ethics Committee of St. Luke's International University
Address	10-1, Akashi-cho, Chuo-ku, Tokyo
Tel	03-5550-2423
Email	kenkyukikaku@luke.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	2018 Year 06 Month 01 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	47
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 06 Month 01 Day
Date of IRB	2018 Year 04 Month 27 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 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 03 Month 29 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036480