Relative effectiveness of two nasal continuous positive airway pressure devices in VLBW infants: first report from a multicenter, randomized, controlled trial

Introduction

Nasal continuous positive airway pressure (nCPAP) is accepted as an effective and relatively complication-free method of respiratory support of premature infants [1, 2]. We intended to compare the effectiveness of two nCPAP devices/approaches (Hudson prongs/bubble (H), and Infant Flow (IF)), in different groups of very low birth weight infants in a large trial.

Methods

Infants weighing 750 to 1,500 g, gestational age <32 weeks, were enrolled from April 2006 to July 2008 at 12 centers. The newborns, categorized into three study groups, were randomly assigned to one of the nCPAP devices in the first 6 hours of life. Study group A (n = 119) were neonates placed immediately on nCPAP. Group B (n = 157) were placed on nCPAP after receiving surfactant. Group C (n = 56) were treated with conventional ventilation and nCPAP was used as the method of weaning from mechanical ventilation.

Results

There were no statistically significant differences between the two devices with regard to treatment success, pneumothorax or bronchopulmonary dysplasia. The incidence of severe nasal complications was lower in the infants treated with Infant Flow: 0.8% (IF), 6.6.% (H) (P = 0.01) in group A; 0.6% (IF), 5.1% (H) (P = 0.01) in group B; and 0% (IF), 5.3% (H) (P = 0.1) in group C. The incidence of necrotizing enterocolitis was also lower in the group A infants treated with Infant Flow: 2.5% (IF), 8.3% (H) (P = 0.03).

Conclusion

(1) The two nCPAP methods are comparable with regard to the incidence of pulmonary complications and primary effectiveness. (2) The Infant Flow method resulted in fewer severe nasal complications.