UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040246 |
|---|---|
| Receipt number | 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 12:46:03 |
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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
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
katsuorobi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045857
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
