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
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
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
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
