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A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of SURFAXIN® (Lucinactant), in Very Low Birth Weight (VLBW) Infants at Risk for Developing Bronchopulmonary Dysplasia
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 infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).
Details
| Lead sponsor | Windtree Therapeutics |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 136 |
| Start date | 2005-02 |
| Completion | 2006-07 |
Conditions
- Respiratory Distress Syndrome, Newborn
- Premature Birth
- Bronchopulmonary Dysplasia
Interventions
- Lucinactant 175 mg/kg
- Lucinactant 90 mg/kg
- Placebo
Primary outcomes
- Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks — 36 weeks post-menstrual age (PMA)
Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age - All-cause Mortality — 36 weeks PMA
Countries
United States