drugset / Trial / NCT01860014
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-01
- Completion
- 2011-03
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Beractant | Other / unclassified | 100 mg/kg | Other |
| Comparator | Poractant alfa | Other / unclassified | 100 mg/kg | Other |