Clinical Trial: Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Brief 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 Summary:
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.
Sponsor: University of Missouri-Columbia
Current Primary Outcome: Change in Inflammation [ Time Frame: baseline and at 24 hours and 48 hours after intervention. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: intraoperative ]Review of subject charts at study conclusion
- Pulmonary Hemorrhage [ Time Frame: intraoperative ]Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.
- Change in number of tracheal macrophages [ Time Frame: baseline and at 24 hours and 48 hours after intervention. ]measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate
Original Secondary Outcome: Same as current
Information By: University of Missouri-Columbia
Dates:
Date Received: May 19, 2016
Date Started: July 2013
Date Completion:
Last Updated: October 24, 2016
Last Verified: September 2016