UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014545
Receipt number R000016919
Scientific Title Evaluation of Neonatal Adrenal Function by Serum Steroids Assay
Date of disclosure of the study information 2014/07/14
Last modified on 2018/05/04 20:43:06

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Basic information

Public title

Evaluation of Neonatal Adrenal Function by Serum Steroids Assay

Acronym

Evaluation of Neonatal Adrenal Function by Using Steroids Assay

Scientific Title

Evaluation of Neonatal Adrenal Function by Serum Steroids Assay

Scientific Title:Acronym

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

1st name
Middle name
Last name Masayuki Miwa

Organization

Keio University School of Medicine

Division name

Departmento of Pediatrics

Zip code


Address

Shinanomachi35, Shinjuku, Tokyo

TEL

03-3353-1211

Email

m38miwa@z2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Miwa

Organization

National Hospital Organization Saitama Hospital

Division name

Departmento of Pediatrics

Zip code


Address

Suwa2-1, Wakoshi, Saitma, Japan

TEL

048-462-1101

Homepage URL


Email

m38miwa@z2.keio.jp


Sponsor or person

Institute

Departmento of Pediatrics, National Hospital Organization(NHO) Saitama Hospital

Institute

Department

Personal name



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)



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

2014 Year 07 Month 14 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

Terminated

Date of protocol fixation

2014 Year 05 Month 21 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016919


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name