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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001700
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Metropolitan Children's medical center Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001801

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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