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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040246
Receipt No. R000045857
Scientific Title Prevention of CMV infection via breast milk by Microwave treatment.
Date of disclosure of the study information 2020/04/30
Last modified on 2020/04/27

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Basic information
Public title Prevention of CMV infection via breast milk by Microwave treatment.
Acronym PreMMie Study
Scientific Title Prevention of CMV infection via breast milk by Microwave treatment.
Scientific Title:Acronym PreMMie Study
Region
Japan

Condition
Condition Cytomegaloviral infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Microwave treatment has been known as effective in vitro for prevention of CMV infection via breast milk and also results in less decrease in breast milk composition. We would like to know if microwave treatment is effective for prevention of CMV infection in very preterm infants via breast milk.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes infectious rate of CMV at 36 weeks of PMA.
Key secondary outcomes weight gain during NICu stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Microwave treatment 500W 40sec
Interventions/Control_2 thawed frozen breast milk
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
25 weeks-old <=
Age-upper limit
30 weeks-old >
Gender Male and Female
Key inclusion criteria Maternal age is more than or equal to 20 years old. In addition, her baby must be more than or equal to 25 weeks of gestation and less than 30 weeks of gestation.
Key exclusion criteria 1)mother's own milk is not available or inappropriate due to HIV/HTLV-1 carrier.
2)the amount of mother's own milk is less than that of formula or donor human milk
3)death during early neonatal period
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Katsumi
Middle name
Last name Mizuno
Organization Showa University School of Medicine
Division name Department of Pediatrics
Zip code 142-8666
Address 1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL 0337848709
Email katsuorobi@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Katsumi
Middle name
Last name Mizuno
Organization Showa University School of Medicine
Division name Department of Pediatrics
Zip code 142-8666
Address 1-5-8 Hatanodai
TEL 0337848709
Homepage URL https://mmmlab.sakura.ne.jp/kmizuno.uh-oh.jp/wp-admin/post.php?post=6&action=edit
Email katsuorobi@med.showa-u.ac.jp

Sponsor
Institute Showa University of Medicine
Institute
Department

Funding Source
Organization Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel 0337848709
Email katsuorobi@med.showa-u.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
2020 Year 04 Month 30 Day

Related information
URL releasing protocol https://mmmlab.sakura.ne.jp/kmizuno.uh-oh.jp/wp-admin/post.php?post=6&action=edit
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
2020 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2022 Year 12 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
2020 Year 04 Month 27 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045857

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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