UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Setting reference value of serum creatinine and serum cystatin C by an enzymatic method in neonates.
Title of the study (Brief title)	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	Shunsuke Shinozuka
Organization	National Hospital Organization Saitama National Hospital
Division name	Department of Pediatrics
Address	2-1,Suwa,Wako City, Saitama, Japan
TEL	048-462-1101
Email	shino@wakho.hosp.go.jp

Public contact
Name of contact person	Shunsuke Shinozuka
Organization	National Hospital Organization Saitama National Hospital
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028580