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Completed

NCT Number: NCT01860014

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

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.

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Key information

Conditions

Pulmonary Hemorrhage

Age range

1 hour–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zekai Tahir Burak Hospital

Ankara, 06120, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Major congenital abnormalities
  • Without parental consent

Treatment and study plan

Poractant alfa

Drug

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

Other names: Curosurf

Beractant

Drug

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

Other names: Survanta

Primary outcomes

  1. Oxygen requirement

    Time frame: 6 hour

    We will evaluate the need of oxygen support within 6 hour after surfactant

Secondary outcomes

  1. Mortality

    Time frame: 4 weeks

    We will compare the rate of mortality between the groups during neonatal period

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 22, 2013
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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