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 |
Study for preparation of criteria of nipple size in low birth weight infants
Study for preparation of criteria of nipple size in low birth weight infants
Study for preparation of criteria of nipple size in low birth weight infants
Study for preparation of criteria of nipple size in low birth weight infants
Japan |
Low birth weight infant
Pediatrics |
Others
NO
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
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.
Confirmatory
Pragmatic
Not applicable
Three observers evaluate the nipple size for bottle feeding at the date when the infant reached fixed body weight.
Interventional
Factorial
Non-randomized
Open -no one is blinded
No treatment
7
Treatment
Maneuver |
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.
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.
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.
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.
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.
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.
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.
Not applicable |
Not applicable |
Male and Female
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
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
210
1st name | |
Middle name | |
Last name | Isamu Hokuto |
St. Marianna university hospital
Neonatal intensive care unit
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
044-977-8111
isamuhokuto@gmail.com
1st name | |
Middle name | |
Last name | Isamu Hokuto |
St. Marianna university hospital
Neonatal intensive care unit
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
044-977-8111
isamuhokuto@gmail.com
St. Marianna University School of Medicine
Self funding
Self funding
Pigeon Corporation
NO
聖マリアンナ医科大学病院(神奈川県)
2019 | Year | 03 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 03 | Month | 01 | Day |
2019 | Year | 03 | Month | 01 | Day |
2019 | Year | 02 | Month | 20 | Day |
2019 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040676