Performance Evaluation of XBreathe Neo™ High-flow Nasal Cannula Oxygenation in Late Preterm Neonates with Respiratory Distress: A Feasibility Study

Background: Respiratory distress affects a significant proportion of term and preterm neonates and may progress to respiratory failure. We recently developed the XBreathe Neo ™ to offer an accessible high-flow nasal cannula (HFNC) in resource-limited settings. The study aimed to evaluate the performance of XBreathe Neo ™ compared to standard continuous positive airway pressure (CPAP) in neonates with respiratory distress. Materials and Methods: Late preterm and term neonates (gestational age >34 weeks) diagnosed with respiratory distress (SpO 2 ≤ 90%, Downe score > 4) were randomized to receive XBreathe Neo ™ HFNC or standard CPAP. Peripheral capillary oxygen saturation (SpO 2 ), respiratory rate, heart rate (HR), and Downe score were measured every 15 min for the first 3 hours, then every 2 hours for 48 hours. Results: SpO 2 levels did not significantly differ between XBreathe Neo ™ and CPAP groups over 48 hours ( P = 0.396). After 3 hours, SpO 2 significantly increased in both groups ( P < 0.001) and stabilized within the target range (91–95%). Tachypnoea was significantly reduced after 3 hours of oxygenation in both groups ( P < 0.001). Heart rates in the XBreathe Neo ™ group initially exceeded 160 bpm ( P < 0.001) but decreased to the normal range (<159 beats per minute) after 3 hours of oxygenation. Downe scores were higher at baseline but improved to non-distress levels in both groups, with CPAP showing a higher reduction ( P = 0.004). No adverse events or treatment failures were observed. Conclusion: XBreathe Neo ™ HFNC is safe and demonstrated comparable efficacy to standard CPAP as a respiratory support modality in late preterm and term neonates.