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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046135
Receipt No. R000052592
Scientific Title Effects of milking mothers of newborns anticipated to feed poorly
Date of disclosure of the study information 2021/11/22
Last modified on 2021/11/22

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Basic information
Public title Effects of milking mothers of newborns anticipated to feed poorly
Acronym Effects of milking mothers of newborns anticipated to feed poorly
Scientific Title Effects of milking mothers of newborns anticipated to feed poorly
Scientific Title:Acronym Effects of milking mothers of newborns anticipated to feed poorly
Region
Japan

Condition
Condition Postpartum mother and new borns
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether milking mothers of new born in preterm or less than 30 percentile of mean gestational age weight,
promote breast feeding and the infants to breast feed at during the early postpartum period.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Milking amount from 1st day to 5th day of puerperium
Key secondary outcomes Percentage of breast feeding, percentage of weight increase of the newnborns, and level of mother satisfaction with breast feeding at the 1 month medical check up.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Milking within 2hours after birth, and 4 times per day till discharge
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 Mothers and newborns born at Nagasaki University Hospital, admitting maternity ward from childbirth to discharge, preterm infants (36 weeks), low birth weight (less 30 percentile than gestational age), ability to understand Japanese.
Key exclusion criteria Newborn with congenital complications affecting feeding (heart disease), malformations (such as cleft lip and palate).
Mothers wishing to control milk (because of HTLV-1 adult T-cell leukemia positive, etc.), and multiple births.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Eto
Organization Nagasaki University
Division name Institute of Biomedical Sciences
Zip code 852-8520
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7922
Email heto@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Yukiko
Middle name
Last name Yoshida
Organization Nagasaki University hospital
Division name General Affairs Division
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7229
Homepage URL
Email y-yu0418@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki 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 Nagasaki University Hospital Clinicalb Research Center
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7726
Email rinshou7726@umin.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
2021 Year 11 Month 22 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 22 Day
Last follow-up date
2022 Year 10 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
2021 Year 11 Month 22 Day
Last modified on
2021 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052592

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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