NCT02834624

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 22 Weeks – 35 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Poractant alfa	Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
DRUG	calfactant	Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-02-01
• Completion: 2015-07-01
• First posted: 2016-07-15
• Last updated: 2017-06-06
• Results posted: 2017-06-06

Locations

1 site across 1 country: United States