UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Neonatal Adrenal Function by Serum Steroids Assay
Title of the study (Brief title)	Evaluation of Neonatal Adrenal Function by Using Steroids Assay
Region	Japan

Condition
Condition	newborn infants
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The porpose is to be able to properly evaluate the adrenal function in newborn infants and is to set the reference value by using tandem mass spectolometry.
Basic objectives2	Others
Basic objectives -Others	The second porpose is to be able to use steroids properly to newborn infants
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Outcome is to create a reference value of serum steroids hormon consentration of newborn, each gestational age.
Key secondary outcomes

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	Not applicable
Age-upper limit	2 months-old >
Gender	Male and Female
Key inclusion criteria	newborn infant under 2 months age. however in case of preterm infant, we use corrected age.
Key exclusion criteria	newborn infants with complications such as heart disease, chromosomal abnormality and so on.
Target sample size	900

Research contact person
Name of lead principal investigator	Masayuki Miwa
Organization	Keio University School of Medicine
Division name	Departmento of Pediatrics
Address	Shinanomachi35, Shinjuku, Tokyo
TEL	03-3353-1211
Email	m38miwa@z2.keio.jp

Public contact
Name of contact person	Masayuki Miwa
Organization	National Hospital Organization Saitama Hospital
Division name	Departmento of Pediatrics
Address	Suwa2-1, Wakoshi, Saitma, Japan
TEL	048-462-1101
Homepage URL
Email	m38miwa@z2.keio.jp

Sponsor
Institute	Departmento of Pediatrics, National Hospital Organization(NHO) Saitama Hospital
Institute
Department

Funding Source
Organization	Department of Pediatrics, Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 07 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 21 Day
Anticipated trial start date	2014 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We collect blood simultaneously with the time of neonatl mass screening.

Management information
Registered date	2014 Year 07 Month 13 Day
Last modified on	2018 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016919