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Nasal high-frequency percussive ventilation versus nasal continuous positive airway pressure in term and preterm neonates exhibiting respiratory distress: a randomized controlled trial (TONIPEP; NCT 02030691)

Objective. To determine whether the use of nasal, high-frequency percussive ventilation (nHFPV) to manage neonatal respiratory distress decreases the regional cerebral oxygen saturation (rScO2) below that afforded by nasal continuous positive airway pressure (nCPAP). Design. Monocentric, prospective, randomized, monocentric, open-label, non-inferiority crossover trial. Patients. Newborns of gestational age (GA) [≥] 33 weeks exhibiting persistent respiratory distress after 10 min of life (Silverman score [≥] 4). Intervention. nHFPV and nCPAP, in succession and in random order. Main outcome measure. Mean rScO2, as revealed by near-infrared spectroscopy (NIRS) performed over the last 5 min of each ventilation mode. To show that nHFPV was not inferior to nCPAP, our a priori calculations required that the lower boundary of the bilateral 95% confidence interval (CI) of the difference between the mean rScO2 values of each ventilation mode should exceed -5. Results. Forty-nine newborns were randomized and 46 were analyzed. The mean ({+/-} standard deviation [SD]) GA and birth weight were 36.4 {+/-} 1.9 weeks and 2,718 {+/-} 497 g. The diagnosis was transient tachypnea in 65% of cases and respiratory distress syndrome in 35%. The mean rScO2 difference during the last 5 min of each ventilation mode (nHFPV minus nCPAP) was -0.7 {+/-} 5.4% (95% CI - 2.25; 0.95). Neither a period effect nor a period-treatment interaction was evident. The mean transcutaneous carbon dioxide values (n = 26) for nCPAP and nHFPV were 7.1 {+/-} 4.8 and 7.9 {+/-} 5.1 kPa, respectively. No harmful or unintentional effect was observed. Conclusion. In our study on newborns of GA [≥] 33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.