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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031830
Receipt No. R000036350
Scientific Title Prevention of hypothermia method of premature baby
Date of disclosure of the study information 2018/03/22
Last modified on 2018/03/21

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Basic information
Public title Prevention of hypothermia method of premature baby
Acronym Prevention of hypothermia method of premature baby
Scientific Title Prevention of hypothermia method of premature baby
Scientific Title:Acronym Prevention of hypothermia method of premature baby
Region
Japan

Condition
Condition Premature baby, hypothermia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 At newborn resuscitation, we test which of lap or plastic bag prevents hypothermia more.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Temperature after hospitalization
adverse event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 As a prevention of hypothermia method, we perform newborn resuscitation using a lap
Interventions/Control_2 As a prevention of hypothermia method, we perform newborn resuscitation using a plastic bag
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

Not applicable
Age-upper limit
1 days-old >
Gender Male and Female
Key inclusion criteria Neonates within 31 weeks for gestational ages
Key exclusion criteria Gestational ages 22 weeks
The patients with the underlying disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimitsu Yanagisawa
Organization Shinshu University School of Medicine
Division name Department of Pediatrics
Zip code
Address 3-1-1,Asahi,Matsumoto 390-8621,Japan
TEL 0263-35-4600
Email tcxp_toshi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimitsu Yanagisawa
Organization Shinshu University School of Medicine
Division name Department of Pediatrics
Zip code
Address 3-1-1,Asahi,Matsumoto 390-8621,Japan
TEL 0263-35-4600
Homepage URL
Email tcxp_toshi@yahoo.co.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization -
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 21 Day
Last modified on
2018 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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