drugset / Trial / NCT01860014

Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage

NCT01860014

Completed 20 enrolled Dr. Sami Ulus Children's Hospital
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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Beractant Other / unclassified 100 mg/kg Other
Comparator Poractant alfa Other / unclassified 100 mg/kg Other