UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and mother and child interaction of low birth weight infants purpose of child care support
Title of the study (Brief title)	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	Keiji Goishi
Organization	National Center for Global Health and Medicine
Division name	Pediatrics
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	Makiko Kabuaki
Organization	National Center for Global Health and Medicine
Division name	Pediatrics
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 11 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Developmental delays of language social area in 6 month low birth weight infants are relevant to high parenting stress.
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031953