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)

Abstract Objective To determine whether the use of nasal, high-frequency percussive ventilation (nHFPV) to manage neonatal respiratory distress decreases the regional cerebral oxygen saturation (rScO 2 ) 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 rScO 2 , 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 rScO 2 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 rScO 2 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. What is already known on the topic Non-invasive high-frequency ventilation is feasible in preterm newborns and seems to improve ventilation compared to nasal CPAP. We previously showed that nasal high-frequency percussive ventilation (nHFPV) was more efficient that nCPAP for respiratory distress management in newborns of gestational age (GA) ≥ 35 weeks. The impact of mechanical ventilation, especially high-frequency modes, on cerebral blood flow in neonates is of concern. What this study adds nHFPV was well-tolerated and non-inferior to nasal CPAP as measured by rScO 2 levels when used to manage respiratory distress at birth in newborns of GA ≥ 33 weeks.