UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027886 |
|---|---|
| Receipt number | R000031953 |
| Scientific Title | Development and mother and child interaction of low birth weight infants purpose of child care support |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2018/06/29 13:09:17 |
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Basic information
Public title
Development and mother and child interaction of low birth weight infants purpose of child care support
Acronym
Development and mother and child interaction of low birth weight infants
Scientific Title
Development and mother and child interaction of low birth weight infants purpose of child care support
Scientific Title:Acronym
Development and mother and child interaction of low birth weight infants
Region
| Japan |
Condition
Condition
low birth weight infant
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate relation about development and temperament of low birth weight infant,parenting stress ,and parent and infant interaction.
Basic objectives2
Others
Basic objectives -Others
It make use of the results for the
child care supports system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Which K type developmental test
Japanese version of PSI parent stress index
Child care environment questionnaire
Infant characteristic questionnaire
Child characteristic questionnaire
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 6 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
low birth weight infant
Key exclusion criteria
Child of HIV-infected mother
External malformations
Serious neurological disorders
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Goishi |
Organization
National Center for Global Health and Medicine
Division name
Pediatrics
Zip code
Address
162-8655 1-21-1, Toyama, Shinjyuku-ku, Tokyo, Japan
TEL
03-3202-7181
kgoishi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Kabuaki |
Organization
National Center for Global Health and Medicine
Division name
Pediatrics
Zip code
Address
162-8655 1-21-1, Toyama, Shinjyuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
kabumaki@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立研究開発法人 国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Developmental delays of language social area in 6 month low birth weight infants are relevant to high parenting stress.
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
| 2014 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Mother who have a good relationship especially "reactive to unpleasant situation" and "promoting social and emotional development" with
their low birth weight infants, they have good development of "language social area in which K type developlopment test.
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031953
