UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022080
Receipt number R000025458
Scientific Title Effects of Positioning for Very Low Birth Weight Infant Movements Three Dimensional Data Analysis
Date of disclosure of the study information 2016/05/28
Last modified on 2019/03/04 22:39:51

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Basic information

Public title

Effects of Positioning for Very Low Birth Weight Infant Movements
Three Dimensional Data Analysis

Acronym

Effects of Positioning for Very Low Birth Weight Infants

Scientific Title

Effects of Positioning for Very Low Birth Weight Infant Movements
Three Dimensional Data Analysis

Scientific Title:Acronym

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

1st name
Middle name
Last name Tetsuo Ikai

Organization

Tokyo Women&#39;s Medical University

Division name

Department of Rehabilitation

Zip code


Address

8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email

ikai.tetsuo@twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuu Uchio

Organization

Tokyo Women&#39;s Medical University

Division name

Department of Rehabilitation

Zip code


Address

8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan

TEL

03-3353-8111

Homepage URL


Email

uchio.yu@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women&#39;s Medical University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11438/_article/-char/ja

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

Main results already published

Date of protocol fixation

2016 Year 01 Month 28 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025458


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name