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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024835
Receipt No. 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

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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
Email 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
Email shino@wakho.hosp.go.jp

Sponsor
Institute National Hospital Organization Saitama National Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028580

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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