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

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ClinicalTrials.gov Identifier: NCT01860014
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, 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.

Condition or disease Intervention/treatment Phase
Pulmonary Hemorrhage Drug: Poractant alfa Drug: Beractant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Study Start Date : March 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Beractant
Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Drug: Poractant alfa
Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Other Name: Curosurf

Active Comparator: Poractant alfa
Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Drug: Beractant
Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Other Name: Survanta




Primary Outcome Measures :
  1. Oxygen requirement [ Time Frame: 6 hour ]
    We will evaluate the need of oxygen support within 6 hour after surfactant


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 4 weeks ]
    We will compare the rate of mortality between the groups during neonatal period



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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital abnormalities
  • Without parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860014


Locations
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Turkey
Zekai Tahir Burak Hospital
Ankara, Turkey, 06120
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
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Principal Investigator: Şenol Bozdağ, MD Zekai Tahir Burak Hospital

Publications of Results:
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Responsible Party: Dilek Dilli, MD, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01860014     History of Changes
Other Study ID Numbers: 306/29 March 2010
306/29 March 2010 ( Other Identifier: Ethics Committee )
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Dilek Dilli, Dr. Sami Ulus Children's Hospital:
Pulmonary hemorrhage
Mortality
Newborn

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Pulmonary Surfactants
Poractant alfa
Beractant
Respiratory System Agents