UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013922 |
|---|---|
| Receipt number | R000016231 |
| Scientific Title | Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial |
| Date of disclosure of the study information | 2014/12/31 |
| Last modified on | 2015/11/03 02:01:30 |
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Basic information
Public title
Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial
Acronym
Feeding tolerance of a formula for premature infants versus donor breast milk: a randomized control trial
Scientific Title
Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial
Scientific Title:Acronym
Feeding tolerance of a formula for premature infants versus donor breast milk: a randomized control trial
Region
| Europe |
Condition
Condition
Neonatology
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the hypothesis that, in the absence of their own mother's milk, the study formula for premature infants can ensure a feeding tolerance not inferior to that of donor breast milk in the first two weeks of life.
Basic objectives2
Others
Basic objectives -Others
clinical, biochemical, Doppler
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase III
Assessment
Primary outcomes
day of life when full enteral feeding of 150 ml / kg is reached
Key secondary outcomes
gastrointestinal hormones at birth, at 8 and 15 days of life;
faecal calprotectin at at birth, at 8 and 15 days of life;
abdominal Doppler velocimetry at birth, at 8 and 15 days of life;
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
formula milk for premature infants
Interventions/Control_2
donor breast milk
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
| 1 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
gestational age less than or equal to 32 weeks
own mother's breast milk absent or insufficient in the first 7 days of life to meet the full infant enteral need start of enteral nutrition in the first 7 days of life
Key exclusion criteria
congenital surgical disease,
major malformation syndromes,
abnormal prenatal Doppler velocimetry (AED and ARED), sepsis in the first 72 hours of life.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Costa Simonetta |
Organization
University Hospital "A. Gemelli", Rome, Italy
Division name
Division of Neonatology
Zip code
Address
L.go A. Gemelli, 8 -00168, Rome, Italy
TEL
+81-0390630154357
simocosta@yahoo.it
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Costa Simonetta |
Organization
University Hospital "A. Gemelli", Rome, Italy
Division name
Division of Neonatology
Zip code
Address
L.go A. Gemelli, 8 -00168, Rome, Italy
TEL
+81-0390630154357
Homepage URL
simocosta@yahoo.it
Sponsor or person
Institute
Romagnoli Costantino
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2014 | Year | 12 | Month | 31 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | 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
| 2014 | Year | 05 | Month | 10 | Day |
Last modified on
| 2015 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016231
| 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 |
