UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035959 |
|---|---|
| Receipt number | R000040676 |
| Scientific Title | Study for preparation of criteria of nipple size in low birth weight infants |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/02/20 17:47:22 |
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Basic information
Public title
Study for preparation of criteria of nipple size in low birth weight infants
Acronym
Study for preparation of criteria of nipple size in low birth weight infants
Scientific Title
Study for preparation of criteria of nipple size in low birth weight infants
Scientific Title:Acronym
Study for preparation of criteria of nipple size in low birth weight infants
Region
| Japan |
Condition
Condition
Low birth weight infant
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose of this study is preparation of standard for selection of appropriate nipple size for bottle feed in low birth weight infants without experience of care giver
Basic objectives2
Others
Basic objectives -Others
If we find appropriate nipple size for bottle feeding, we expect that low birth weight infants would be able to shift from tube feeding to oral feeding more easily.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Three observers evaluate the nipple size for bottle feeding at the date when the infant reached fixed body weight.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Infants between 1000 gram to 1199 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
Interventions/Control_2
Infants between 1200 gram and 1499 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
Interventions/Control_3
Infants between 1500 gram and 1799 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
Interventions/Control_4
Infants between 1800 gram and 1999 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
Interventions/Control_5
Infants between 2000 gram and 2199 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
Interventions/Control_6
Infants between 2200 gram and 2499 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
Interventions/Control_7
Infants between 2500 gram and 2999 gram.
We compare the Peristaltic PLUS nipples SSS and Peristaltic PLUS nipples SS for these infants.
bottle fed infant was observed by same staff.
Observer takes pictures of the mouse of the infant during bottle feeding for the first time use of each nipple SSS and SS.
One observer evaluate two nipples SSS and SS by using evaluation form.
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
Infants whose gestational age between 22 and 36 weeks at birth
and
More than 34 weeks of corrected gestational age
and
started only bottle feeding
Key exclusion criteria
Infants who is difficult sucking due to diseases as mentioned below.
chromosomal anomaly
cleft lip and palate
congenital heart disease
respiratory supported infants
infants who are considered not appropriate this study by staffs
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isamu Hokuto |
Organization
St. Marianna university hospital
Division name
Neonatal intensive care unit
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
TEL
044-977-8111
isamuhokuto@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isamu Hokuto |
Organization
St. Marianna university hospital
Division name
Neonatal intensive care unit
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
TEL
044-977-8111
Homepage URL
isamuhokuto@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
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
Pigeon Corporation
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | 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
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040676
