NCT01860014

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dr. Sami Ulus Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Hour – 1 Week
• Healthy volunteers: Not accepted

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.

Detailed description

The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated with PH included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation. Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates the hospital course of 3-5% of preterm infants with RDS. 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.

Conditions

• Pulmonary Hemorrhage

Interventions

Type	Name	Description
DRUG	Poractant alfa	Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
DRUG	Beractant	Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2013-05-22
• Last updated: 2013-05-22

Locations

1 site across 1 country: Turkey (Türkiye)