UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027120 |
|---|---|
| Receipt number | R000030460 |
| Scientific Title | Exhaustive examination about the cause microbe diagnosis of the fever case in newborn infants. |
| Date of disclosure of the study information | 2017/04/25 |
| Last modified on | 2020/06/08 16:53:53 |
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Basic information
Public title
Exhaustive examination about the cause microbe diagnosis of the fever case in newborn infants.
Acronym
Examination about the cause microbe of the fever case in newborn infants.
Scientific Title
Exhaustive examination about the cause microbe diagnosis of the fever case in newborn infants.
Scientific Title:Acronym
Examination about the cause microbe of the fever case in newborn infants.
Region
| Japan |
Condition
Condition
Fever case in newborn infants
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exhaustive examination about the cause microbe diagnosis of the fever case in newborn infants.
Basic objectives2
Others
Basic objectives -Others
Choice of appropriate antimicrobial or antifungus in the fever case in newborn infants
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
16SrRNA or 18SrRNA detected from serum and Nasopharyngeal swabs
Key secondary outcomes
Identification of the cause microbe
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | months-old | <= |
Age-upper limit
| 3 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Inpatients in newborn infant of fever cases.
Key exclusion criteria
The fever continuation patient who are transferred from other hospital.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhei Tanaka |
Organization
Department of Pediatrics Kawasaki Medical School
Division name
Pediatrics
Zip code
Address
577 Matsushima, Kurashiki, Okayama, Japan 701-0192
TEL
0864621111
yuhei.tuk.first@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuhei Tanaka |
Organization
Department of Pediatrics Kawasaki Medical School
Division name
Pediatrics
Zip code
Address
577 Matsushima, Kurashiki, Okayama, Japan 701-0192
TEL
0864621111
Homepage URL
yuhei.tuk.first@gmail.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
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
| 2017 | Year | 04 | Month | 25 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 05 | Month | 07 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 04 | Month | 25 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030460
