UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention of hypothermia method of premature baby
Title of the study (Brief title)	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	Toshimitsu Yanagisawa
Organization	Shinshu University School of Medicine
Division name	Department of Pediatrics
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	Toshimitsu Yanagisawa
Organization	Shinshu University School of Medicine
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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