UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031830 |
|---|---|
| Receipt number | 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 18:14:25 |
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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
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
tcxp_toshi@yahoo.co.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036350
