UMIN-CTR Clinical Trial

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
Email	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
Email	o.iwata@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046898