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

UMIN ID: C000000405

Registered date:12/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: chronic lung disease in extremely low birth weight infants
• Date of first enrollment: 2006/05/01
• Target sample size: 211
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Death or use home oxygen therapy (HOT) for chronic lung disease
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 0weeks-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Neonatal Research Network Japan
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare