Unique ID issued by UMIN | UMIN000001728 |
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Receipt number | R000002082 |
Scientific Title | Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants |
Date of disclosure of the study information | 2009/03/01 |
Last modified on | 2009/02/23 14:10:26 |
Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Japan |
Extremely Low Birth Weight Infants
Pediatrics |
Others
NO
The objective was to study the efficacy and safety of transpyloric tube feeding compared with gastric tube feeding on the respiratory deterioration in intubated extremely low birth weight infants.
Safety,Efficacy
Exploratory
Pragmatic
Phase III
Chronic lung disease, additional oxygen requirement at 36weeks post conceptional age
failure criteria,respiratory deterioration and intestinal disorder
Chronic lung disease, additional oxygen requirement at 28day of life
Mean Airway Pressure on ventilator
FiO2
FSp95,FiO2 to keep SpO2>95% at rest
RAS,Room Air Saturation
Growth and Development
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
NO
Numbered container method
2
Treatment
Device,equipment |
transpyloric tube feeding group
gastric tube feeding group
0 | weeks-old | <= |
0 | weeks-old | >= |
Male and Female
birth weight less than 1000g
less than 28 weeks gestation
mechanical ventilation had been performed
enteral feeding had been reached 50ml/kg/day
parental consent
intestinal disorder including necrotizing enterocolitis
congenital anomalies such as chromosomal anomalies
congenital heart diseases
hydrops
40
1st name | |
Middle name | |
Last name | Shinya Tanaka |
Osaka Medical Center and Research Institute for Maternal and Child Health
Departments of Neonatology
840 Murodou-cho, Izumi-city, Osaka, Japan
1st name | |
Middle name | |
Last name |
Osaka Medical Center and Research Institute for Maternal and Child Health
Departments of Neonatology
s-tanaka@bca.bai.ne.jp
Osaka Medical Center and Research Institute for Maternal and Child Health
None
Self funding
NO
2009 | Year | 03 | Month | 01 | Day |
Partially published
Completed
2001 | Year | 04 | Month | 01 | Day |
2001 | Year | 06 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 02 | Month | 23 | Day |
2009 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002082
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