Unique ID issued by UMIN | C000000405 |
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Receipt number | R000000491 |
Scientific Title | Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate |
Date of disclosure of the study information | 2006/04/12 |
Last modified on | 2013/10/30 15:29:08 |
Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Randomized, double-blind, multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Randomized, double-blind, placebo-controlled multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Randomized, double-blind, multi center clinical trial for the prevention of chronic lung disease in extremely low birth weight infants with inhaled fluticasone propionate
Japan |
chronic lung disease in extremely low birth weight infants
Pediatrics | Intensive care medicine |
Others
NO
To study the efficacy and complications of inhaled fluticasone propionate started within 24hours after birth for the prevention of chronic lung disease in Japanese extremely low birth weight infants
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Death or use home oxygen therapy (HOT) for chronic lung disease
1. Death
2. Death or Incidence of chronic lung disease at 28days
3. Death or Incidence of chronic lung disease at 36 weeks of postmenstrual age
4. Neurological and developmental outcome at 1 and half year old
5. Neurological and developmental outcome at 3 years of age
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Fluticasone propionate inhalation of 50mcg/puff will be given every 12 hours started within 24 hours after birth for 6 weeks or until extubation in extremely low birth weight infants.
Placebo inhalation (A same dose of Fluticasone propionate of 50mcg/puff) will be given each 12 hours within 24 hours after birth during 6 weeks or until extubation in extremely low birth weight infants.
0 | weeks-old | <= |
0 | weeks-old | >= |
Male and Female
(1)Extremely Low Birth Weight Infants (weighing less than 1000g at birth)
(2)First inhalation to be given within 24 hours after birth
(3)Mechanical ventilation with intubation (2.5mm and over in tube's diameter)
(4)Informed consent to participate to the study is obtained from the guardians
(1)Subjects with sepsis, pneumonia or severe acute infection
(2)Subjects with severe liver dysfunction.
(3)Subjects with suspected immunodeficiency or abnormal adrenal function.
(4)Subjects with uncontrollable hyperglycemia
(5)Subjects with uncontrollable hypertension
(6)Subjects with severe malformation, highly suspected chromosomal abnormality
(7)Subjects with renal dysfunction.
(8)Subjects judged by the investigator to be inappropriate as study subjects.
211
1st name | |
Middle name | |
Last name | Tomohiko Nakamura |
Nagano Children's Hospital
Division of Neonatology
3100 Toyoshina, Azumino city, Nagano, Japan
0263-73-6700
tnakamura@naganoch.gr.jp
1st name | |
Middle name | |
Last name | Tomohiko Nakamura |
Nagano Children's Hospital
Division of Neonatology
3100 Toyoshina, Azumino city, Nagano, Japan
0263-73-6700
http://nrn.shiga-med.ac.jp/
tnakamura@naganoch.gr.jp
Neonatal Research Network Japan
Ministry of Health, Labour and Welfare
Japan
NO
2006 | Year | 04 | Month | 12 | Day |
http://nrn.shiga-med.ac.jp/
Unpublished
http://nrn.shiga-med.ac.jp/
Completed
2005 | Year | 11 | Month | 14 | Day |
2006 | Year | 05 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 08 | Month | 30 | Day |
2013 | Year | 10 | Month | 30 | Day |
2006 | Year | 04 | Month | 12 | Day |
2013 | Year | 10 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000491
Research Plan | |
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