UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023110 |
|---|---|
| Receipt number | R000026594 |
| Scientific Title | Follow-up Investigation on Infant Growth and Nutritional Intake |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2020/01/14 12:33:09 |
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Basic information
Public title
Follow-up Investigation on Infant Growth and Nutritional Intake
Acronym
Follow-up Investigation on Infant Growth and Nutritional Intake
Scientific Title
Follow-up Investigation on Infant Growth and Nutritional Intake
Scientific Title:Acronym
Follow-up Investigation on Infant Growth and Nutritional Intake
Region
| Japan |
Condition
Condition
Formula-fed infant
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the growth of breast-fed and formula-fed infants.
To obtain the factual data on feeding amount and pattern.
Basic objectives2
Others
Basic objectives -Others
Substantial investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Formula intake per day
Body length
Head circumference
Stool characteristics (number, colour, form)
Formula intake per feeding
Number of feeding per day
Number of weaning foods
Others
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Infant at 1 month of age
2. Infant feeding brestmilk or Hohoemi-formula
3. Subjects whose guardian gave written informed consent
Key exclusion criteria
Subjects who are judged as unsuitable for the study by the investigator.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Nakamura |
Organization
Meiji Co., Ltd.
Division name
Food Science Research Laboratories, R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL
0465-37-3661
yoshitaka.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Jinno |
Organization
Meiji Co., Ltd.
Division name
Food Science Research Laboratories, R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL
0465-37-3661
Homepage URL
shinji.jinno@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2017 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/full/10.1080/09168451.2019.1689096
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/09168451.2019.1689096
Number of participants that the trial has enrolled
1053
Results
In this observational study, 1,053 infants were followed-up to 12 months. Body weight, body mass index, and head circumference of Formula A-fed infants were similar to those of breastfed infants. Additionally, there were no differences in the stool consistency and the health condition (infection and allergy prevalence) between the two groups. Formula A-fed infants grew as well as breastfed infants, suggesting the appropriate nutritional composition of Formula A.
Results date posted
| 2020 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There are no difference in gestational age, rate of cesarean section, weight, body mass index, and head circumference at birth between Formula-Fed and breastfed boy infants. In girls, there were significant differences only in rate of cesarean section and birth weight between Formula A-fed and breast-fed girl infants.
Participant flow
We obtained informed consent from 1,053 participants. Finally, 394 (295 breastfed, 99 Formula A-fed) infants were included.
Adverse events
Not applicable
Outcome measures
Body weight, Body mass index, head circumference, stool consistency and Health condition
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Relation between the mode of feeding and the infant growth
Prospective study
Case-control study
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026594
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
