UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049413 |
|---|---|
| Receipt number | R000056265 |
| Scientific Title | The Effects of Recorded Songs by Parents on the Development in Preterm Infants: A randomized controlled study |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2023/05/18 16:48:55 |
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Basic information
Public title
The Effects of Recorded Songs by Parents on the Development in Preterm Infants
Acronym
The Effects of Recorded Songs by Parents on the Development in Preterm Infants
Scientific Title
The Effects of Recorded Songs by Parents on the Development in Preterm Infants: A randomized controlled study
Scientific Title:Acronym
The Effects of Recorded Songs by Parents on the Development in Preterm Infants: A randomized controlled study
Region
| Japan |
Condition
Condition
Preterm infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to investigate the effects of exposing preterm infants to recorded theiar parents's songs on their development and their vital signs. Moreover, the attachment formation between the parents and infants will be studied.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Developmental assessments at 18 months of corrected age using the the Kyoto Scale of Psychological Development (KSPD) test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The recorded songs are played to the infant by a portable music player for 30 minutes or more daily. The investigators play songs recorded by the parents to preterm infants. The intervention starts at 7 days or 28 weeks after birth and continues up to 37 weeks.
Interventions/Control_2
Conventional care is provided for control patients.
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
| 6 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Preterm infants born at less than 33 weeks of gestation
Key exclusion criteria
Major congenital anomaly, intraventricular hemorrhage (Grade 3 or 4) , cerebral hemorrhage , periventricular leukomalacia, neonatal seizure
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | YOSHINORI |
| Middle name | |
| Last name | AOKI |
Organization
University of Miyazaki
Division name
Pediatrics
Zip code
8891601
Address
5200 Kihara Kyotake-cho Miyazaki-shi Miyazaki
TEL
0985850989
yoshinori_aoki@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | YOSHINORI |
| Middle name | |
| Last name | AOKI |
Organization
Miyazaki university
Division name
Pediatrics
Zip code
8891601
Address
5200 Kihara Kyotake-cho Miyazaki-shi Miyazaki
TEL
0985850989
Homepage URL
yoshinori_aoki@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
University of Miyazaki
Address
5200 Kihara Kyotake-cho Miyazaki-shi Miyazaki
Tel
0985859403
rinken@med.miyazaki-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 | 07 | 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
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056265
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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