UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045709 |
|---|---|
| Receipt number | R000052172 |
| Scientific Title | A randomized control study on the effect of sugar-water or artificial milk supplementation for establishment of exclusive breastfeeding |
| Date of disclosure of the study information | 2021/10/09 |
| Last modified on | 2024/04/11 12:34:40 |
* 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 randomized control study on the effect of sugar-water or artificial milk supplementation for establishment of exclusive breastfeeding
Acronym
A randomized control study on the effect of sugar-water or artificial milk supplementation for establishment of exclusive breastfeeding
Scientific Title
A randomized control study on the effect of sugar-water or artificial milk supplementation for establishment of exclusive breastfeeding
Scientific Title:Acronym
A randomized control study on the effect of sugar-water or artificial milk supplementation for establishment of exclusive breastfeeding
Region
| Japan |
Condition
Condition
Healthy neonates
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of glucose water or formula supplementation for the subsequent establishment of exclusive breastfeeding in neonates who confirmed breastfeeding deficiency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of exclusive breastfeeding at age of one month
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Glucose water supplementation is applied to neonates with breastmilk insufficiency.
Interventions/Control_2
Formula supplementation is applied to neonates with breastmilk insufficiency.
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
| 5 | days-old | > |
Gender
Male and Female
Key inclusion criteria
Newborns with suspected breastfeeding insufficiency and need for fluid administration
Key exclusion criteria
Neonates who are medically considered to need artificial milk supplementation.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Futatani |
Organization
Toyama prefectural central hospital
Division name
Department of pediatrics
Zip code
930-8550
Address
2-2-78 Nishinagae, Toyama city, Toyama, Japan
TEL
076-424-1531
tfutatani@hotmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Futatani |
Organization
Toyama prefectural central hospital
Division name
Department of pediatrics
Zip code
930-8550
Address
2-2-78 Nishinagae, Toyama city, Toyama, Japan
TEL
076-424-1531
Homepage URL
tfutatani@hotmail.com
Sponsor or person
Institute
Toyama prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama prefectural central hospital
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
Toyama prefectural central hospital
Address
2-2-78 Nishinagae, Toyama city, Toyama, Japan
Tel
076-424-1531
usudak@tch.pref.toyama.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052172
