UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024993 |
|---|---|
| Receipt number | R000028747 |
| Scientific Title | Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2016/11/25 10:47:39 |
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Basic information
Public title
Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients
Acronym
Efficacy in usage of enteral nutrient with immuno-balance modulation action
Scientific Title
Study for efficacy of usage of enteral nutrient with immuno-balance modulation action in perioperative management of pediatric patients
Scientific Title:Acronym
Efficacy in usage of enteral nutrient with immuno-balance modulation action
Region
| Japan |
Condition
Condition
Hirschsprung's disease, Atresia ani, Congenital biliary dilatation, GERD
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effect of MEIN or other enteral nutrients on postoperative inflammatory condition in perioperative nutritional management in pediatric patients with Hirschsprung disease, ano-rectal malformation, biliary dilatation, and gastroesophageal reflux disease . We also evaluate the nutritional status and fecal condition after surgery, the incidence of infectious complications, the number of hospital days and so on.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of postoperative inflammatory condition
Key secondary outcomes
the nutritional status and fecal condition after surgery, the incidence of infectious complications, the number of hospital days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In the control group, the following enteral nutrient will be administered (breast milk or artificial milk for infants, Racol for infants).
Dose and duration: Before surgery, the patient will take enteral nutrients at 60 to 100 kcal / kg per day for 3 days. After the surgery, enteral nutrition will restart within 2 to 3 days after surgery, and continue until 6th postoperative day.
Interventions/Control_2
In contrast, immunomodulatory nutrition is administered in the test group.
Dose and duration: Before surgery, the patient will take enteral nutrients at 60 to 100 kcal / kg per day for 3 days. After the surgery, enteral nutrition will restart within 2 to 3 days after surgery, and continue until 6th postoperative day.
The study period is from December 1, 2016 to March 31, 2018.
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
| 6 | months-old | <= |
Age-upper limit
| 48 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Hirschsprung's disease, Ano-rectal malformation, Congenital biliary dilatation, GERD
Key exclusion criteria
Patients whose enteral nutrition is impossible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouji Masumoto |
Organization
University of Tsukuba Hospital
Division name
Department of Pediatric Surgery, Faculty of Medicine
Zip code
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki, JAPAN
TEL
029-853-3094
kmasu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouji Masumoto |
Organization
University of Tsukuba Hospital
Division name
Department of Pediatric Surgery, Faculty of Medicine
Zip code
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki, JAPAN
TEL
029-853-3094
Homepage URL
kmasu@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
MEIJI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2016 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2016 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028747
