UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032092 |
|---|---|
| Receipt number | R000036612 |
| Scientific Title | Continuous blood glucose measurement in neonates |
| Date of disclosure of the study information | 2018/05/11 |
| Last modified on | 2023/04/10 23:28:06 |
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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
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
a-ohishi@hama-med.ac.jp
Sponsor or person
Institute
Maternal-Fetal and Neonatal Care Center, Hamamatsu University Hospital
Institute
Department
Personal name
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
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
20
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 10 | Day |
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
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036612
