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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032092
Receipt No. R000036612
Scientific Title Continuous blood glucose measurement in neonates
Date of disclosure of the study information 2018/05/11
Last modified on 2019/04/06

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Basic information
Public title Continuous blood glucose measurement in neonates
Acronym Continuous blood glucose measurement in neonates
Scientific Title Continuous blood glucose measurement in neonates
Scientific Title:Acronym Continuous blood glucose measurement in neonates
Region
Japan

Condition
Condition Neonatal hypoglycemia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of validity of measurements and safety for continuous blood glucose measurement device in neonate
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of continuous blood glucose monitoring device in neonate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Attach a continuous blood glucose monitoring device to the thigh of a newborn baby, soon after birth for 6 hours.
Interventions/Control_2
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
1 days-old <=
Age-upper limit
1 days-old >=
Gender Male and Female
Key inclusion criteria term nenonate
Key exclusion criteria Neonate with inborn diagnosis of congenital anomaly
Neonate who entered the neonatal intensive care unit due to premature birth or complications
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Ohishi
Organization Hamamatsu University Hospital
Division name Maternal-Fetal and Neonatal Care Center
Zip code 4313192
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu City, Shizuoka prefecture, 431-3192 Japan
TEL 053-435-2312
Email a-ohishi@hama-med.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Ohishi
Organization Hamamatsu University Hospital
Division name Maternal-Fetal and Neonatal Care Center
Zip code 4313192
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu City, Shizuoka prefecture, 431-3192 Japan
TEL 053-435-2312
Homepage URL
Email a-ohishi@hama-med.ac.jp

Sponsor
Institute Maternal-Fetal and Neonatal Care Center, Hamamatsu University Hospital
Institute
Department

Funding Source
Organization Maternal-Fetal and Neonatal Care Center, Hamamatsu University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hamamatsu University Hospital
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu City, Shizuoka prefecture, 431-3192 Japan
Tel 053-435-2111
Email rinri@hama-med.ac.jp

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 05 Month 11 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 11 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 04 Month 03 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036612

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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