Supplementary Material for: NIV NAVA versus Nasal CPAP in Premature Infants: A Randomized Clinical Trial

Background: Noninvasive ventilation is recommended for neonatal respiratory distress to avoid adverse effects of invasive ventilation. Objective: The aim of this study was to compare the feasibility of noninvasive neurally adjusted ventilatory assist (NIV NAVA) and continuous positive airway pressure (CPAP) in preterm newborn infants. Methods: Forty preterm infants (gestational age 28+0 to 36+6 weeks) requiring CPAP and supplemental oxygen (FiO2 >0.23) for respiratory distress at <48 h of postnatal age were randomized to NIV NAVA or CPAP. The primary endpoint was the inspired oxygen concentration 12 h after study inclusion. Secondary endpoints were the duration of oxygen treatment, total duration of respiratory support, parenteral nutrition, blood gas values, patient comfort, need for invasive ventilation, and treatment complications. Results: The mean FiO2 at the time of study inclusion was 0.29 in both groups. After 12 h of treatment, FiO2 was 0.26 ± 0.07 and 0.26 ± 0.04 in the NIV NAVA and CPAP groups, respectively (difference 0.006, 95% CI –0.4 to 0.5), with no difference between the groups during the course of noninvasive ventilation (p = 0.80). Seven patients (35%) in the NIV NAVA group and 10 (50%) in the control group required intubation (difference 15%, 95% CI –15.5 to 4.3, p = 0.36). Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups. Conclusions: In the present trial, NIV NAVA had no statistically significant effect on oxygen requirements or the need for invasive ventilation in preterm newborn infants.