Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants.

OBJECTIVE To determine whether nasal continuous positive airway pressure (NCPAP) given with nasal prongs compared with nasal mask reduces the rate of intubation and mechanical ventilation in preterm infants within 72 hours of starting therapy. METHODS Infants <31 weeks' gestation treated with NCPAP were randomly assigned to receive it via either prongs or mask. Randomization was stratified by gestational age (<28 weeks, 28-30 weeks) and according to whether NCPAP was started as a primary treatment for respiratory distress or postextubation. Infants were intubated and ventilated if they fulfilled 2 or more of 5 failure criteria (worsening signs of respiratory distress; recurrent apnea treated with mask positive pressure ventilation; fraction of inspired oxygen >0.4 to keep oxygen saturation >88% sustained for 30 minutes; pH <7.2 on 2 blood gases ≥ 30 minutes apart; Pco(2) >9 kPa [68 mm Hg] on 2 blood gases ≥ 30 minutes apart) within 72 hours of starting therapy. The groups were treated the same in all other respects. We recorded relevant secondary outcomes and analyzed data by using the intention-to-treat principle. RESULTS We enrolled 120 infants. Thirty-two of 62 (52%) infants randomly assigned to prongs were intubated within 72 hours, compared with 16/58 (28%) of those randomly assigned to mask (P = .007). There were no statistically significant differences between the groups in any secondary outcomes. CONCLUSIONS In premature infants, NCPAP was more effective at preventing intubation and ventilation within 72 hours of starting therapy when given via nasal masks compared with nasal prongs.