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

Pulmonary Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860014
• Other study ID #: 306/29 March 2010
• Secondary ID: 306/29 March 201
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: May 20, 2013
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2013
• Source: Dr. Sami Ulus Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Week

Eligibility

Inclusion Criteria:

• Premature infants <1500 g

• Within first week of life

Exclusion Criteria:

• Major congenital abnormalities

• Without parental consent

Related Conditions & MeSH terms

• Hemorrhage
• Pulmonary Hemorrhage

Intervention

Drug:
• Poractant alfa
Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
• Beractant
Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Rogers D. Pulmonary haemorrhage, surfactant, and low-birthweight babies. Lancet. 1993 Mar 13;341(8846):698. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen requirement	We will evaluate the need of oxygen support within 6 hour after surfactant	6 hour
Secondary	Mortality	We will compare the rate of mortality between the groups during neonatal period	4 weeks