UMIN-CTR Clinical Trial

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