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

Dr. Sami Ulus Children's Hospital

Status: Completed

Conditions: Pulmonary Hemorrhage

Treatments: Drug: Beractant; Drug: Poractant alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT01860014

306/29 March 2010 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 1 hour to 1 week old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premature infants <1500 g
• Within first week of life

Exclusion criteria

• Major congenital abnormalities
• Without parental consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Beractant

Active Comparator group

Description:

Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Treatment:

Drug: Poractant alfa

Poractant alfa

Active Comparator group

Description:

Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Treatment:

Drug: Beractant