Back to resultsComparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Primary Purpose
Pulmonary Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Poractant alfa
Beractant
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hemorrhage focused on measuring Pulmonary hemorrhage, Mortality, Newborn
Eligibility Criteria
Inclusion Criteria:
- Premature infants <1500 g
- Within first week of life
Exclusion Criteria:
- Major congenital abnormalities
- Without parental consent
Sites / Locations
- Zekai Tahir Burak Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Beractant
Poractant alfa
Arm Description
Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Outcomes
Primary Outcome Measures
Oxygen requirement
We will evaluate the need of oxygen support within 6 hour after surfactant
Secondary Outcome Measures
Mortality
We will compare the rate of mortality between the groups during neonatal period
Full Information
NCT ID
NCT01860014
First Posted
May 20, 2013
Last Updated
May 20, 2013
Sponsor
Dr. Sami Ulus Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01860014
Brief Title
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Official Title
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hemorrhage
Keywords
Pulmonary hemorrhage, Mortality, Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beractant
Arm Type
Active Comparator
Arm Description
Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Arm Title
Poractant alfa
Arm Type
Active Comparator
Arm Description
Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Intervention Type
Drug
Intervention Name(s)
Poractant alfa
Other Intervention Name(s)
Curosurf
Intervention Description
Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Intervention Type
Drug
Intervention Name(s)
Beractant
Other Intervention Name(s)
Survanta
Intervention Description
Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
Primary Outcome Measure Information:
Title
Oxygen requirement
Description
We will evaluate the need of oxygen support within 6 hour after surfactant
Time Frame
6 hour
Secondary Outcome Measure Information:
Title
Mortality
Description
We will compare the rate of mortality between the groups during neonatal period
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature infants <1500 g
Within first week of life
Exclusion Criteria:
Major congenital abnormalities
Without parental consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şenol Bozdağ, MD
Organizational Affiliation
Zekai Tahir Burak Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Hospital
City
Ankara
ZIP/Postal Code
06120
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
8095608
Citation
Rogers D. Pulmonary haemorrhage, surfactant, and low-birthweight babies. Lancet. 1993 Mar 13;341(8846):698. doi: 10.1016/0140-6736(93)90469-w. No abstract available.
Results Reference
result
Learn more about this trial
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
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