UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041063 |
|---|---|
| Receipt number | R000046898 |
| Scientific Title | Promotion of vocal development by mother's voice for preterm infants |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2022/07/19 22:42:43 |
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Basic information
Public title
Promotion of vocal development by mother's voice for preterm infants
Acronym
Always with Mom
Scientific Title
Promotion of vocal development by mother's voice for preterm infants
Scientific Title:Acronym
Always with Mom
Region
| Japan |
Condition
Condition
preterm baby
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether recorded mother's voice improves development of infants at corrected 18 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive and verbal development quotient at corrected 18 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exposure to recorded mother's voice
Interventions/Control_2
Standard care
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 | weeks-old | <= |
Age-upper limit
| 52 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
Preterm infants requiring NICU care longer than 2 weeks
Key exclusion criteria
1) Congenital malformation
2) Chromosomal disorders
3) Hearing impairment
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Osuke |
| Middle name | |
| Last name | Iwata |
Organization
Nagoya City University
Division name
pediatrics
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city
TEL
052-853-8246
o.iwata@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Osuke |
| Middle name | |
| Last name | Iwata |
Organization
Nagoya City University
Division name
Pediatrics
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city
TEL
052-853-8246
Homepage URL
o.iwata@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology(MEXT)
Grant-in-Aid for Scientific Research (KAKENHI)
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
Clinical research management center, Nagoya city university hospital
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city
Tel
052-851-5511
clinical_research@med.nagoya-cu.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 | 07 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 | 07 | Month | 10 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046898
