UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016711 |
|---|---|
| Receipt number | 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 13:45:05 |
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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
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
chsmt@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Pediatric Surgery, Department of Surgery, Kobe University Graduate School of Medicine
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019390
