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. What is already known on the topic What this study adds ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT 02030691 ### Funding Statement This Study has been founded by the "Appel d'offre interne 2013" grant from the University Hospital Centre of Bordeaux, France. ### Author Declarations All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data relevant to the study are provided in the manuscript.