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Recruitment status
Unique ID issued by UMIN UMIN000016711
Receipt No. R000019390
Scientific Title Clinical evaluation of the efficacy and safety of the guideline of oral ingestion of NaCl for children with ileostomy
Date of disclosure of the study information 2015/04/01
Last modified on 2017/03/06

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Basic information
Public title Clinical evaluation of the efficacy and safety of the guideline of oral ingestion of NaCl for children with ileostomy
Acronym Clinical evaluation of oral ingestion of NaCl for children with ileostomy
Scientific Title Clinical evaluation of the efficacy and safety of the guideline of oral ingestion of NaCl for children with ileostomy
Scientific Title:Acronym Clinical evaluation of oral ingestion of NaCl for children with ileostomy
Region
Japan

Condition
Condition ileostomy
Classification by specialty
Gastrointestinal surgery Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of the guideline of oral ingestion of NaCl for children with ileostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Prevention of hyponatremia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sodium supplementation
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 days-old <=
Age-upper limit
180 days-old >=
Gender Male and Female
Key inclusion criteria Newborns and infants who are created ileostomy before 30 days old.
Those who take milk orally after undergoing ileostomy creation.
Key exclusion criteria Those who have cardiac disease.
Those who have renal disease.
Those who take diuretic continuously.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chieko Hisamatsu
Organization Kobe University Graduate School of Medicine
Division name Division of Pediatric Surgery, Department of Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5942
Email chsmt@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chieko Hisamatsu
Organization Kobe University Graduate School of Medicine
Division name Division of Pediatric Surgery, Department of Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5942
Homepage URL
Email chsmt@med.kobe-u.ac.jp

Sponsor
Institute Division of Pediatric Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kobe Children's Hospital, Kakogawa Central City Hospital, Japanese Red Cross Society Himeji Hospital
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 兵庫県立こども病院(兵庫県)、加古川中央市民病院(兵庫県)、姫路赤十字病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 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
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 04 Day
Last modified on
2017 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019390

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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