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

NCT01860014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-05-22

No results posted yet for this study

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.

Conditions

  • Pulmonary Hemorrhage

Interventions

DRUG

Poractant alfa

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

DRUG

Beractant

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

Sponsors & Collaborators

  • Dr. Sami Ulus Children's Hospital

    lead OTHER

Principal Investigators

  • Şenol Bozdağ, MD · Zekai Tahir Burak Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-01-31
Completion
2011-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01860014 on ClinicalTrials.gov