UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Positioning for Very Low Birth Weight Infant Movements Three Dimensional Data Analysis
Title of the study (Brief title)	Effects of Positioning for Very Low Birth Weight Infants
Region	Japan

Condition
Condition	1.Very Low Birth Weight Infants 2.Term Infants
Classification by specialty	Pediatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the immediate effects of positioning for very low birth weight infant movements.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	immediate changes of the arms and legs movements after two minutes of positioning intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
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	Device,equipment
Interventions/Control_1	Evaluate with and without positioning mats
Interventions/Control_2	Evaluate without positioning mats
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	0 weeks-old <=
Age-upper limit	8 weeks-old >=
Gender	Male and Female
Key inclusion criteria	Very low birth weight infants weighing less than 1500 g at birth In the Tokyo Women's Medical University Hospital Informed consent to participate to the study is obtained from the parents
Key exclusion criteria	Subjects judged by the doctors to have neurological disorders Subjects need the mechanical ventilators or oxygen therapy Subjects judged by the investigators to be inappropriate as study subjects
Target sample size	30

Research contact person
Name of lead principal investigator	Tetsuo Ikai
Organization	Tokyo Women's Medical University
Division name	Department of Rehabilitation
Address	8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	ikai.tetsuo@twmu.ac.jp

Public contact
Name of contact person	Yuu Uchio
Organization	Tokyo Women's Medical University
Division name	Department of Rehabilitation
Address	8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	uchio.yu@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Metropolitan 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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 28 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 01 Month 28 Day
Anticipated trial start date	2016 Year 04 Month 28 Day
Last follow-up date	2017 Year 02 Month 15 Day
Date of closure to data entry	2017 Year 02 Month 15 Day
Date trial data considered complete	2017 Year 02 Month 15 Day
Date analysis concluded	2017 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11438/_article/-char/ja
Results
Other related information

Management information
Registered date	2016 Year 04 Month 26 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025458