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
Phase 3
- Conditions
- chronic lung disease in extremely low birth weight infants
- Registration Number
- JPRN-C000000405
- Lead Sponsor
- eonatal Research Network Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 211
Inclusion Criteria
Not provided
Exclusion Criteria
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method