UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027886
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kabumaki@gmail.com

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.