Status:
TERMINATED
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
Lead Sponsor:
Windtree Therapeutics
Conditions:
Respiratory Distress Syndrome, Newborn
Premature Birth
Eligibility:
All Genders
3-10 years
Phase:
PHASE2
Brief Summary
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature inf...
Detailed Description
Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first ...
Eligibility Criteria
Inclusion
- Premature infants between 600 and 900 grams birth weight
- Intubated and on mechanical ventilation
- Sustained (\>= 30 minutes) fraction of inspired oxygen (FiO₂) \>= 0.30 within 8 hours prior to randomization
Exclusion
- Mother has prolonged rupture of membranes ≥ 2 weeks
- Culture-proven sepsis
- High grade intraventricular hemorrhage (IVH)
- Congenital heart disease
- Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
- FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
- FiO₂\< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
- Concomitant use of any other surfactant within the first 48 hours of life
- Prior use of nitric oxide
- Prior use of steroids
- Current participation in any other clinical trial or has received an experimental drug or used an experimental device
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00215540
Start Date
February 1 2005
End Date
July 1 2006
Last Update
June 13 2012
Active Locations (1)
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1
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States, 18976-3646