UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024835 |
|---|---|
| Receipt number | R000028580 |
| Scientific Title | Setting reference value of serum creatinine and serum cystatin C by an enzymatic method in neonates. |
| Date of disclosure of the study information | 2016/11/15 |
| Last modified on | 2018/05/29 07:59:47 |
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Basic information
Public title
Setting reference value of serum creatinine and serum cystatin C by an enzymatic method in neonates.
Acronym
Setting reference value of serum creatinine and cystatin C in neonates.
Scientific Title
Setting reference value of serum creatinine and serum cystatin C by an enzymatic method in neonates.
Scientific Title:Acronym
Setting reference value of serum creatinine and cystatin C in neonates.
Region
| Japan |
Condition
Condition
normal neonate
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the reference range of serum creatinine and serum cystatine C by an enzymatic method in neonates.
Basic objectives2
Others
Basic objectives -Others
To establish the reference range of serum creatinine and serum cystatine C by an enzymatic method in neonates.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum creatinine and cystatine C at 4 days and a month old
Key secondary outcomes
renal length at a month old
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
| 1 | days-old | <= |
Age-upper limit
| 50 | days-old | > |
Gender
Male and Female
Key inclusion criteria
1)normal neonates
-gestational age of more than 37 weeks, less than 42 weeks
-birth weight of more than 2500g, less than 4000g
2) Written informed consent must be obtained from patient's parents
Key exclusion criteria
1) hospitalized in NICU
2) neonatal asphyxia
-Apgar score of less than 7 points
3) oligoamnios
4) solitary kidney
5) judged inappropriate for the clinical trial by doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Shinozuka |
Organization
National Hospital Organization Saitama National Hospital
Division name
Department of Pediatrics
Zip code
Address
2-1,Suwa,Wako City, Saitama, Japan
TEL
048-462-1101
shino@wakho.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Shinozuka |
Organization
National Hospital Organization Saitama National Hospital
Division name
Department of Pediatrics
Zip code
Address
2-1,Suwa,Wako City, Saitama, Japan
TEL
048-462-1101
Homepage URL
shino@wakho.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Saitama National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Saitama National Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Tokyo Medical Center
National Hospital Organization Tochigi Medical Center
Fuji Heavy Industries Health Insurance Society Ota Memorial Hospital
Sanokousei General Hospital
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
| 2016 | Year | 11 | Month | 15 | 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
| 2016 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
descriptive epidemiology
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028580
