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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035959
Receipt No. 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

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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
Email 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
Email isamuhokuto@gmail.com

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040676

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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