UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043806 |
|---|---|
| Receipt number | R000050002 |
| Scientific Title | Evaluation of infant's formula intake by cup-feeding assuming disaster: an open trial |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2025/04/18 15:30:02 |
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Basic information
Public title
Evaluation of infant's formula intake by cup-feeding assuming disaster
Acronym
Cup-feeding trial
Scientific Title
Evaluation of infant's formula intake by cup-feeding assuming disaster: an open trial
Scientific Title:Acronym
Cup-feeding trial
Region
| Japan |
Condition
Condition
Healthy infant and adult
Classification by specialty
| Pediatrics | Dental medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine of the usefulness of cup- feeding in disaster by conducting an open trial with infants in 1 to 2 months old and 4 to 5 months old and their guardians. The trial is assumed a situation where guardians who have no experience in cup-feeding feed a stored formula to their infant by cup-feeding in an evacuation life during disaster.
Basic objectives2
Others
Basic objectives -Others
Usefulness of cup-feeding
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Infant's formula intake per one cup-feeding by guardian who has no experience in cup feeding
Key secondary outcomes
- Spilled amount, feeding time and state of infant and guardian per one cup-feeding
- Infant's formula intake per one cup-feeding by guardian who has experience in cup-feeding
- Success ratio of cup-feeding
- Difference between each evaluation item between the initial test and the additional test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Cup feeding
- The formula used for trial: Infant formula.
- Feeding method: Guardians feed the infant with cup-feeding using a cup.
- Feeding number of times: 1 time for study subjects who participated in the initial study only, 2 times for study subjects who participated in the additional study.
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
| 1 | months-old | <= |
Age-upper limit
| 5 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy infant (1 to 2 months old or 4 to 5 months old) who has undergone a 1 or 4 month medical check-up and his/her guardian (parents, grandparents or cohabiter of the infant excluding minor)
2. Subject who voluntarily agreed in writing with sufficient understanding after the guardian, who is the proxy for his/her infant and the subject of the study, received sufficient explanation about the purpose and contents of this study
3. Both the infant and his/her guardian are inexperienced in cup-feeding
Key exclusion criteria
1. Infant who has allergy to cow's milk
2. Infant who has no experience in suckling infant formula
3. Infant or his/her guardian who has participated in other clinical trial within three months
4. Infant with notable serious illness and morphological abnormalities
5. Infant or his/her guardian who is judged ineligible by investigator or sub-investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Utsumi |
Organization
Showa University, School of Dentistry
Division name
Department of Hygiene and Oral Health
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa, Tokyo, 142-8555, JAPAN
TEL
03-3784-8172
akemi@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Utsumi |
Organization
Showa University, School of Dentistry
Division name
Department of Hygiene and Oral Health
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa, Tokyo, 142-8555, JAPAN
TEL
03-3784-8172
Homepage URL
akemi@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pediatrics, Showa University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Univ. IRB
Address
1-5-8 Hatanodai, Shinagawa, Tokyo, 142-8555, JAPAN
Tel
03-3784-8129
m-rinri@ofc.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
| 2022 | Year | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 07 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050002
