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, 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000405

Enrollment

211

Registered

2006-04-12

Start date

2006-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic lung disease in extremely low birth weight infants

Interventions

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 inhalati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Death or use home oxygen therapy (HOT) for chronic lung disease	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTomohiko Nakamura

Nagano Children's Hospital Division of Neonatology

tnakamura@naganoch.gr.jp0263-73-6700

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026