UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009323 |
|---|---|
| Receipt number | R000010948 |
| Scientific Title | Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery. |
| Date of disclosure of the study information | 2012/11/12 |
| Last modified on | 2018/05/20 20:11:43 |
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Basic information
Public title
Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Acronym
Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Scientific Title
Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Scientific Title:Acronym
Efficacy of an enteral feeding protocol on nutritional support after pediatric cardiac surgery.
Region
| Japan |
Condition
Condition
pediatric cardiovascular surgery
Classification by specialty
| Pediatrics | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the safety and improvement of nutrition support with an enteral feeding protocol
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the time taken to initiate nutrition support, the proportion of the estimated average requirement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
nutrition support with an enteral feeding protocol after pediatric cardiovascular surgery
Interventions/Control_2
without an enteral feeding protocol
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
| 1 | months-old | <= |
Age-upper limit
| 120 | months-old | > |
Gender
Male and Female
Key inclusion criteria
children after cardiovascular surgery in intensive care unit
Key exclusion criteria
patients with endocrine disease,disorder of metabolism, heart failure, hypothermia management, bowel ischemia or gastrointestinal bleeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Yoshimura |
Organization
Nagoya City University
Division name
Department of Anesthesiology and Medical Crisis Management
Zip code
Address
1-Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
09045874090
s.yoshimura0829@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Yoshimura |
Organization
Nagoya City University
Division name
Department of Anesthesiology and Medical Crisis Management
Zip code
Address
1-Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
09045874090
Homepage URL
s.yoshimura0829@gmail.com
Sponsor or person
Institute
Department of Anesthesiology and Medical Crisis Management, Nagoya City University
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
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
| 2012 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.aaic.net.au/document/?D=20140621
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
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 13 | 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
| 2012 | Year | 11 | Month | 12 | Day |
Last modified on
| 2018 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
