Status:
UNKNOWN
Prevention of Chronic Lung Disease (CLD) in Preterm Infants
Lead Sponsor:
China Medical University, China
Collaborating Sponsors:
National Taiwan University Hospital
Taipei Medical University Hospital
Conditions:
Respiratory Distress Syndrome
Chronic Lung Disease of Prematurity
Eligibility:
All Genders
30-4 years
Phase:
PHASE4
Brief Summary
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However,...
Detailed Description
After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and ai...
Eligibility Criteria
Inclusion
- Infant with birth weight between 500-1500 gram
- Severe respiratory distress syndrome and requires mechanical ventilation with FIO2 \> 60% shortly after birth
Exclusion
- Severe congenital anomalities
- Lethal cardiopulmonary status at birth
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00883532
Start Date
April 1 2009
End Date
April 1 2013
Last Update
August 8 2012
Active Locations (1)
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1
China Medical University
Taichung, Taiwan, China