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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Hemorrhage

Intervention / Treatment
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* Drug: Poractant alfa
* Drug: Beractant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature infants <1500 g Within first week of life Exclusion Criteria: Major congenital abnormalities Without parental consent

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beractant<br>Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage | Drug: Poractant alfa<br>* Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage<br>* Other names: Curosurf;|
| Active Comparator: Poractant alfa<br>Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage | Drug: Beractant<br>* Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage<br>* Other names: Survanta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen requirement | We will evaluate the need of oxygen support within 6 hour after surfactant | 6 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | We will compare the rate of mortality between the groups during neonatal period | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary hemorrhage, Mortality, Newborn