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Clinical Trial Summary

Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.


Clinical Trial Description

Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.

Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01923844
Study type Interventional
Source Ege University
Contact
Status Completed
Phase Phase 4
Start date March 2012
Completion date April 2013

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