drugset / Trial / NCT02834624

Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

NCT02834624

Completed 30 enrolled University of Missouri-Columbia
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2013-07
Primary completion
2015-02
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calfactant Protein / enzyme biologic 3 unknown Other
Comparator Poractant alfa Other / unclassified 3 unknown Other