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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01860014

Enrollment

Registered

2013-05-22

Start date

2010-03-31

Completion date

2011-03-31

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hemorrhage

Keywords

Pulmonary hemorrhage, Mortality, Newborn

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.

Interventions

DRUGPoractant alfa

Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage

DRUGBeractant

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 1 Weeks

Healthy volunteers

Inclusion criteria

* Premature infants \<1500 g * Within first week of life

Exclusion criteria

* Major congenital abnormalities * Without parental consent

Design outcomes

Primary

Measure	Time frame	Description
Oxygen requirement	6 hour	We will evaluate the need of oxygen support within 6 hour after surfactant

Secondary

Measure	Time frame	Description
Mortality	4 weeks	We will compare the rate of mortality between the groups during neonatal period

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026