Supplementary Material for: NIV NAVA versus Nasal CPAP in Premature Infants: A Randomized Clinical Trial Kallio M. Mahlman M. Koskela U. Aikio O. Suo-Palosaari M. Pokka T. Saarela T. Hallman M. 10.6084/m9.figshare.9771620.v1 https://karger.figshare.com/articles/dataset/Supplementary_Material_for_NIV_NAVA_versus_Nasal_CPAP_in_Premature_Infants_A_Randomized_Clinical_Trial/9771620 <b><i>Background:</i></b> Noninvasive ventilation is recommended for neonatal respiratory distress to avoid adverse effects of invasive ventilation. <b><i>Objective:</i></b> 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. <b><i>Methods:</i></b> Forty preterm infants (gestational age 28+0 to 36+6 weeks) requiring CPAP and supplemental oxygen (FiO<sub>2</sub> >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. <b><i>Results:</i></b> The mean FiO<sub>2</sub> at the time of study inclusion was 0.29 in both groups. After 12 h of treatment, FiO<sub>2</sub> 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 (<i>p</i> = 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, <i>p</i> = 0.36). Time to intubation, gas exchange, vital parameters, pain scale, treatment complications, and neonatal outcome did not differ between the groups. <b><i>Conclusions:</i></b> In the present trial, NIV NAVA had no statistically significant effect on oxygen requirements or the need for invasive ventilation in preterm newborn infants. 2019-09-05 08:38:51 Intubation Neonatal lung disease Neurally adjusted ventilatory assist Noninvasive ventilation Respiratory distress