UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001700 |
|---|---|
| Receipt number | R000001801 |
| Scientific Title | A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis. |
| Date of disclosure of the study information | 2009/02/10 |
| Last modified on | 2013/09/29 15:38:40 |
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Basic information
Public title
A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis.
Acronym
Nebulized 3% hypertonic saline solution treatment in hospitalized infants with RS viral bronchiolitis.
Scientific Title
A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis.
Scientific Title:Acronym
Nebulized 3% hypertonic saline solution treatment in hospitalized infants with RS viral bronchiolitis.
Region
| Japan |
Condition
Condition
RS viral bronchiolitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate efficacy and safety of nebulized 3 % hypertonic saline solution treatment compared to nebulized 0.9 % saline solution treatment in hospitalized infants which do not need ventilator management with RS viral bronchiolitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
length of hospital stay; time to satisfy discharge criteria
Key secondary outcomes
Actual length of hospital stay
Change of clinical severity score of hospitalization and 72hr plus and minus 12hr after hospitalization
Duration of O2 administration
Number of additional inhalation
Rate of ventilator use
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nebulized 3% saline solution + beta stimulator
Interventions/Control_2
nebulized 0.9% saline solution + beta stimulator
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
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The patient of the RS virus infectious disease with Rspositive rirus antigen swiftness kit.
2)A patient diagnosed acute bronchiolitis by physicians with following i) and ii).
i)the first episode of wheezing
ii)The patient has either of rhinorrhea, coughing, tachypnea, retractive breathing or decreased breath sounds on auscultation.
3)A patient equal to or less than age 12 months
4)A patient need hospitalization.
5)Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria
1)pCO2 is more than 60 mm Hg by venous blood gas or SpO2 is under 95 % under administration of oxygen.
2)diagnosed episode of wheezing previously.
3)Cerebral palsy, congenital heart desease, lung disease, muscular disorder, malformed syndrome, immune deficiency disorder
4)a patient who was born by premature birth equal to or less than several a week 35 weeks for gestational ages
5)a patients administrated palivizumab.
6)a patients with apnea
7)Judged a patients needed intubation by the physicians.
8)Judged inappropriate for this study by the physicians.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Hasegawa |
Organization
Tokyo Metropolitan Children's medical center
Division name
general pediatrics
Zip code
Address
2-8-29 Musashidai Futyuushi Tokyo
TEL
042-300-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Morikawa |
Organization
Tokyo Metropolitan Children's medical center Hospital
Division name
Department of clinical research
Zip code
Address
2-8-29 Musashidai Futyuushi Tokyo
TEL
042-300-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Children's medical center Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
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
| 2009 | Year | 02 | Month | 10 | 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
| 2008 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 10 | Day |
Last modified on
| 2013 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001801
