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Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Premature Birth Clinical Trial

Official title:
A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Clinical Trial Summary

The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.

Clinical Trial Description

Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01294852
Study type Interventional
Source Ankara University
Contact Saadet Arsan, Professor
Phone 90 312 5956390
Email Saadet.Arsan@medicine.ankara.edu.tr
Status Recruiting
Phase N/A
Start date January 2010
Completion date June 2012
View Details
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