Unique ID issued by UMIN | UMIN000013922 |
---|---|
Receipt number | R000016231 |
Scientific Title | Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial |
Date of disclosure of the study information | 2014/12/31 |
Last modified on | 2015/11/03 02:01:30 |
Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial
Feeding tolerance of a formula for premature infants versus donor breast milk: a randomized control trial
Feeding tolerance of a formula for premature infants versus donor breast milk in the first two weeks of life: a randomized not-inferiority trial
Feeding tolerance of a formula for premature infants versus donor breast milk: a randomized control trial
Europe |
Neonatology
Pediatrics |
Others
NO
To assess the hypothesis that, in the absence of their own mother's milk, the study formula for premature infants can ensure a feeding tolerance not inferior to that of donor breast milk in the first two weeks of life.
Others
clinical, biochemical, Doppler
Exploratory
Others
Phase III
day of life when full enteral feeding of 150 ml / kg is reached
gastrointestinal hormones at birth, at 8 and 15 days of life;
faecal calprotectin at at birth, at 8 and 15 days of life;
abdominal Doppler velocimetry at birth, at 8 and 15 days of life;
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
YES
Central registration
2
Prevention
Food |
formula milk for premature infants
donor breast milk
Not applicable |
1 | weeks-old | >= |
Male and Female
gestational age less than or equal to 32 weeks
own mother's breast milk absent or insufficient in the first 7 days of life to meet the full infant enteral need start of enteral nutrition in the first 7 days of life
congenital surgical disease,
major malformation syndromes,
abnormal prenatal Doppler velocimetry (AED and ARED), sepsis in the first 72 hours of life.
70
1st name | |
Middle name | |
Last name | Costa Simonetta |
University Hospital "A. Gemelli", Rome, Italy
Division of Neonatology
L.go A. Gemelli, 8 -00168, Rome, Italy
+81-0390630154357
simocosta@yahoo.it
1st name | |
Middle name | |
Last name | Costa Simonetta |
University Hospital "A. Gemelli", Rome, Italy
Division of Neonatology
L.go A. Gemelli, 8 -00168, Rome, Italy
+81-0390630154357
simocosta@yahoo.it
Romagnoli Costantino
Self funding
Self funding
NO
2014 | Year | 12 | Month | 31 | Day |
Unpublished
Completed
2014 | Year | 12 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2014 | Year | 05 | Month | 10 | Day |
2015 | Year | 11 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016231