UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049549 |
|---|---|
| Receipt number | R000056417 |
| Scientific Title | Feeding techniques to child with cleft lip and palate |
| Date of disclosure of the study information | 2022/11/18 |
| Last modified on | 2022/11/18 12:20:03 |
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Basic information
Public title
Feeding techniques to child with cleft lip and palate
Acronym
feeding techniques to cleft lip/palate children
Scientific Title
Feeding techniques to child with cleft lip and palate
Scientific Title:Acronym
feeding techniques to cleft lip/palate children
Region
| Japan |
Condition
Condition
cleft lip and/or palate
Classification by specialty
| Pediatrics | Oral surgery | Dental medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the nurses' feeding techniques to children with cleft lip and palate
Basic objectives2
Others
Basic objectives -Others
To confirm the effectiveness of the movie how to use the long nipple bottle or cleft li p and palate bottle.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participant' voice, motion capture, nine of Freedom inertial measurement Unit, myoelectric sensor
Key secondary outcomes
Check list for Kumagai Method
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
instructional video for feeding method
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurses and students
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Ueki |
Organization
Kyushu University
Division name
Medical science
Zip code
813-0017
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka
TEL
092-642-6748
ueki.shingo.388@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Ueki |
Organization
Kyushu University
Division name
Medical science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka
TEL
092-642-6748
Homepage URL
ueki.shingo.388@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medical science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Kyushu University
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka
Tel
092-642-6748
ueki.shingo.388@m.kyushu-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 | 11 | Month | 18 | 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
16
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056417
