UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050633 |
|---|---|
| Receipt number | R000057676 |
| Scientific Title | A systematic review of the usefulness of lipid emulsions in pediatric patients with TPN |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2025/03/19 10:58:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A systematic review of the usefulness of lipid emulsions in pediatric patients with TPN
Acronym
A systematic review of the usefulness of lipid emulsions in pediatric patients with TPN
Scientific Title
A systematic review of the usefulness of lipid emulsions in pediatric patients with TPN
Scientific Title:Acronym
A systematic review of the usefulness of lipid emulsions in pediatric patients with TPN
Region
| Japan |
Condition
Condition
Pediatric patients with TPN
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of lipid emulsion in pediatric patients with TPN
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usefulness of lipid emulsion in pediatric TPN patients
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Database: PubMed, Ichushi-Web
2. Clinical Trial
3. keywords: (Fat Emulsions, Intravenous) AND (Parenteral Nutrition, Total)
Key exclusion criteria
-
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | IIJIMA |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432474401
h-iijima@c-yaku.or.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | IIJIMA |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
260-0025
Address
9-2 Tonyacho, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432474401
Homepage URL
h-iijima@c-yaku.or.jp
Sponsor or person
Institute
Chiba Pharmaceutical Association
Institute
Department
Personal name
Funding Source
Organization
Japan Pharmaceutical Association
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
Not applicable
Address
Not applicable
Tel
Not applicable
-@-
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
| 2023 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
This study protocol is not available to the public.
Publication of results
Published
Result
URL related to results and publications
This study protocol is not available to the public.
Number of participants that the trial has enrolled
356
Results
Preterm infants benefit from parenteral nutrition containing omega-3 fatty acids.
It is hoped that lipid emulsions containing fish oil (FO) will also be sold in Japan.
Results date posted
| 2025 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pediatric, premature baby, Extremely low birth weight babies, infant
Participant flow
Not applicable
Adverse events
Not applicable
Outcome measures
Efficacy of lipid emulsion
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Database: PubMed, Ichushi-Web
2. Clinical Trial
3. keywords: (Fat Emulsions, Intravenous) AND (Parenteral Nutrition, Total)
This is a systematic review and therefore not subject to ethical review.
Management information
Registered date
| 2023 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057676
