J M B Pinheiro1, Q Santana-Rivas1, C Pezzano1,2. 1. Department of Pediatrics, Albany Medical College, Albany, NY, USA. 2. Cardiorespiratory Services, Albany Medical Center, Albany, NY, USA.
Abstract
OBJECTIVE: To compare the effectiveness of surfactant delivery via endotracheal tube (ETT) using an intubation-surfactant-rapid extubation approach with premedication) vs laryngeal mask airway (LMA) in preventing the need for mechanical ventilation in preterm neonates with moderate respiratory distress syndrome (RDS). STUDY DESIGN:Moderately preterm infants diagnosed with RDS, receiving nasal continuous positive airway pressure with FiO2 0.30 to 0.60, were randomized to two groups at age 3 to 48 h. Those in the ETT group were intubated following premedication with atropine and morphine, whereas the LMA group received only atropine. Both groups received calfactant before a planned reinstitution of nasal continuous positive airway pressure, and had equivalent pre-specified criteria for subsequent mechanical ventilation and surfactant retreatment. The primary outcome was failure of surfactant treatment strategy to avoid mechanical ventilation; we differentiated early from late failures to assess the contribution of potential mechanisms such as respiratory depression versus less-effective surfactant delivery. Secondary outcomes addressed efficacy and safety end points. RESULT: Sixty-one patients were randomized, one excluded and 30 analyzed in each group, with similar baseline characteristics. Failure rate was 77% in the ETT group and 30% in the LMA group (P<0.001). The difference was related to early failure, as late failure rates did not differ between groups. FiO2 decrease after surfactant and rates of adverse events were similar between groups. CONCLUSION:Surfactant therapy through an LMA decreases the proportion of newborns with moderate RDS who require mechanical ventilation, when compared with a standard endotracheal intubation procedure with sedation. The efficacy of surfactant in decreasing RDS severity appears similar with both methods. Morphine premedication likely contributed to early post-surfactant failures.
RCT Entities:
OBJECTIVE: To compare the effectiveness of surfactant delivery via endotracheal tube (ETT) using an intubation-surfactant-rapid extubation approach with premedication) vs laryngeal mask airway (LMA) in preventing the need for mechanical ventilation in preterm neonates with moderate respiratory distress syndrome (RDS). STUDY DESIGN: Moderately preterm infants diagnosed with RDS, receiving nasal continuous positive airway pressure with FiO2 0.30 to 0.60, were randomized to two groups at age 3 to 48 h. Those in the ETT group were intubated following premedication with atropine and morphine, whereas the LMA group received only atropine. Both groups received calfactant before a planned reinstitution of nasal continuous positive airway pressure, and had equivalent pre-specified criteria for subsequent mechanical ventilation and surfactant retreatment. The primary outcome was failure of surfactant treatment strategy to avoid mechanical ventilation; we differentiated early from late failures to assess the contribution of potential mechanisms such as respiratory depression versus less-effective surfactant delivery. Secondary outcomes addressed efficacy and safety end points. RESULT: Sixty-one patients were randomized, one excluded and 30 analyzed in each group, with similar baseline characteristics. Failure rate was 77% in the ETT group and 30% in the LMA group (P<0.001). The difference was related to early failure, as late failure rates did not differ between groups. FiO2 decrease after surfactant and rates of adverse events were similar between groups. CONCLUSION: Surfactant therapy through an LMA decreases the proportion of newborns with moderate RDS who require mechanical ventilation, when compared with a standard endotracheal intubation procedure with sedation. The efficacy of surfactant in decreasing RDS severity appears similar with both methods. Morphine premedication likely contributed to early post-surfactant failures.
Authors: H Verder; P Albertsen; F Ebbesen; G Greisen; B Robertson; A Bertelsen; L Agertoft; B Djernes; E Nathan; J Reinholdt Journal: Pediatrics Date: 1999-02 Impact factor: 7.124
Authors: Andrea N Trembath; Allison H Payne; Tarah T Colaizy; Edward F Bell; Michele C Walsh Journal: Semin Perinatol Date: 2016-09-13 Impact factor: 3.300