UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030300 |
|---|---|
| Receipt number | R000034603 |
| Scientific Title | Efficacy of early human milk fortification for very low birth weight infants |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2023/12/12 09:27:01 |
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Basic information
Public title
Efficacy of early human milk fortification for very low birth weight infants
Acronym
early human milk fortification
Scientific Title
Efficacy of early human milk fortification for very low birth weight infants
Scientific Title:Acronym
early human milk fortification
Region
| Japan |
Condition
Condition
very low birth weight infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compair early HMF and delayed HMF on safty and growth of VLBWI, after minimalizing individual difference of human milk component by targeted (individualized) HMF.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anthropometric measurement at 37th week corrected gestation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Human milk fortification will be started when volume of enteral feeding reach 20ml/kg/day after age of day 3. Parenteral nutrition will be continued untill enteral feeding reach 120~140ml/kg/day. Then, targeted HMF will be started after 24 hours or more.
Interventions/Control_2
Human milk fortification will be started when volume of enteral feeding reach 100ml/kg/day, as in a conventional method. Parenteral nutrition will be continued untill enteral feeding reach 120~140ml/kg/day. Then, targeted HMF will be started after 24 hours or more.(Same as Intervention 1)
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 | days-old | < |
Age-upper limit
| 120 | days-old | > |
Gender
Male and Female
Key inclusion criteria
very low birth weight infant(birth weight less than 1500g) who are born at Showa University Hospital
Key exclusion criteria
1) congenital anormally
2) surgical disease of gastrointestinal tract
3) sever asphixia (5min Apgar Score<3)
4) patients who were thouth to be inadequate candidate by attending physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Miyazawa |
Organization
Showa University School of Medicin
Division name
Department of Pediatrics
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8565
kitaba@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tokuo |
| Middle name | |
| Last name | Miyazawa |
Organization
Showa University School of Medicine
Division name
Department of Pediatrics
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8565
Homepage URL
miyazawa.t@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8022
gakuji@ofc.showa-u.ac.jp
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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034603
| 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 |
