UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012339 |
|---|---|
| Receipt number | R000014330 |
| Scientific Title | Serum periostin levels in infants with acute RS virus bronchitis |
| Date of disclosure of the study information | 2013/11/19 |
| Last modified on | 2015/05/20 10:33:21 |
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Basic information
Public title
Serum periostin levels in infants with acute RS virus bronchitis
Acronym
PERSII study
Scientific Title
Serum periostin levels in infants with acute RS virus bronchitis
Scientific Title:Acronym
PERSII study
Region
| Japan |
Condition
Condition
Acute RS virus bronchitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the serum periostin levels in infants with acute RS virus bronchitis.
Basic objectives2
Others
Basic objectives -Others
#1: To compare the serum periostin levels in acute RS virus bronchitis with control.
#2: To see the chronological changes in serum periostin levels in acute RS virus bronchitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compare the serum periostin leves between control group and acute RS virus bronchitis group (modified asthma predictive index (+) and modified asthma predictive index (-)).
Key secondary outcomes
We investigate the chronological changes in periostin levels in acute RS virus bronchitis group.
We investigate the relationship between serum periostin levels and disease severity by modified pulmonary index score in acute RS virus bronchitis group.
We investigate the relationship between serum periostin levels and Th2-related molecules in acute RS virus bronchitis group.
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
| 0 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
group 1:Patients who were admitted to the hospital for acute RS virus bronchitis( modified asthma predictive index(+/-))
group 2:food allergic patients
(positive control)
group 3:surgery scheduled patients (negative control)
Key exclusion criteria
1.Patients with heart disease
2.Patients with bronchial asthma
3.Patients with allergic rhinitis
4.Patients with renal disease
5.Patients with bone disease
6.Patients with muscle disease
7.Patients with malignant tumor
8.Patients who received systemic administration of steroids within one month
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Katsunuma |
Organization
The Jikei University Daisan Hospital
Division name
Pediatrics
Zip code
Address
4-11-1,Izumihoncho,Komae-shi,Tokyo
TEL
03-3480-1151
tkatsunuma@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Akashi |
Organization
The Jikei University Daisan Hospital
Division name
Pediatrics
Zip code
Address
4-11-1,Izumihoncho,Komae-shi,Tokyo
TEL
03-3480-1151
Homepage URL
akashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
The Jikei University Daisan Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toho University Ohashi medical Center
The Fraternity Memorial Hospital
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
東京慈恵会医科大学附属第三病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 19 | 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
| 2013 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the levels of serum periostin in children with acute RS virus bronchitis.
Management information
Registered date
| 2013 | Year | 11 | Month | 19 | Day |
Last modified on
| 2015 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
