Respiratory Distress Syndrome Clinical Trial
Official title:
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Premature infants frequently have trouble breathing after birth. If the respiratory disorder
is caused by surfactant deficiency or dysfunction, the disease is treated with a medication
called surfactant that is given to the infant through a tube inserted into the windpipe.
This study will compare the safety of two of the commonly used surfactants, poractant and
calfactant,in the United States. Poractant has added chemicals called phospholipids which
are known to cause inflammation and irritation in the body of premature infants. The
investigators will compare this to another similar surfactant that does not contain these
chemicals by looking at samples from the windpipe, while the tube is in place, and from
blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to
treat respiratory distress syndrome in preterm infants compared to poractant.
30 infants were randomized to receive either poractant or calfactant for Respiratory
Distress Syndrome.
Tracheal aspirates were obtained to look for increase in macrophage and blood samples were
drawn to look for markers of inflammation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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