UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031000 |
|---|---|
| Receipt number | R000035392 |
| Scientific Title | Development of system for providing donor human milk from human milk bank |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2021/01/27 09:13:40 |
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Basic information
Public title
Development of system for providing donor human milk from human milk bank
Acronym
donor milk from human milk bank
Scientific Title
Development of system for providing donor human milk from human milk bank
Scientific Title:Acronym
donor milk from human milk bank
Region
| Japan |
Condition
Condition
preterm infant
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the system which provides donor human milk safely.
Basic objectives2
Others
Basic objectives -Others
to compare infants' growth, laboratory data, duration of parenteral nutrition, and morbidity between infants with donor milk and without donor milk.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
duration of parental nutrition
Key secondary outcomes
growth (weight, height, head circumference), days of age returned to birth weight, blood test, morbidity (chronic lung disease, retinopathy of prematurity, late-onset sepsis)
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
| Food |
Interventions/Control_1
to start enteral nutrition within 24 hours of birth, if own mother's milk is not affordable, donor human milk derived from the human milk bank is provided until parenteral nutrition is unnecessary.
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
low birth weight infants, preterm infants, congenital heart diseases, post-operative state of GI tract
Key exclusion criteria
the condition that enteral nutrition is not appropriate
Target sample size
500
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
03-3784-8565
katsuorobi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoichirou |
| Middle name | |
| Last name | Sakurai |
Organization
Showa University Koto Toyosu Hospital
Division name
Department of Pediatrics
Zip code
153-8577
Address
5-1-38 Toyosu, Koto-ku, Tokyo
TEL
03-6204-6000
Homepage URL
https://jhmba.or.jp/
katsuorobi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Showa University Koto Toyosu Hospital
Address
5-1-38 Toyosu
Tel
03-6204-6000
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
昭和大学江東豊洲病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2041 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2041 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2041 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2041 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035392
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
