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

Not Applicable

Completed

• Conditions: Pulmonary Hemorrhage
• Interventions: Drug: Beractant; Drug: Poractant alfa

• Registration Number: NCT01860014
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2011-03
• Status Verified: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-20
• Last Update Submitted: 2013-05-20
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Major congenital abnormalities
• Without parental consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poractant alfa	Beractant	Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Beractant	Poractant alfa	Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Primary Outcome Measures

Name	Time	Method
Oxygen requirement	6 hour	We will evaluate the need of oxygen support within 6 hour after surfactant

Secondary Outcome Measures

Name	Time	Method
Mortality	4 weeks	We will compare the rate of mortality between the groups during neonatal period

Trial Locations

Locations (1)

Zekai Tahir Burak Hospital; 🇹🇷 Ankara, Turkey