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

<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 (FiO₂ &gt;0.23) for respiratory distress at &lt;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 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 (<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.

**背景：** 针对新生儿呼吸窘迫（neonatal respiratory distress），推荐采用无创通气（noninvasive ventilation）以规避有创通气（invasive ventilation）带来的不良影响。**目的：** 本研究旨在对比早产新生儿（preterm newborn infants）采用无创神经调节辅助通气（neurally adjusted ventilatory assist，NAVA，即NIV NAVA）与持续气道正压通气（continuous positive airway pressure，CPAP）的可行性。**方法：** 将40例胎龄（gestational age）为28+0至36+6周、于出生后年龄（postnatal age）＜48小时内因呼吸窘迫需接受持续气道正压通气及补充氧气（吸入氧分数（fraction of inspired oxygen，FiO₂）＞0.23）的早产新生儿随机分为NIV NAVA组与CPAP组。本研究的主要终点为入组研究后12小时的吸入氧浓度；次要终点包括氧疗时长、呼吸支持总时长、肠外营养（parenteral nutrition）使用情况、血气指标、患者舒适度、有创通气需求及治疗并发症。**结果：** 两组患者入组研究时的平均吸入氧分数均为0.29。治疗12小时后，NIV NAVA组与CPAP组的吸入氧分数分别为0.26±0.07与0.26±0.04（组间差值为0.006，95%置信区间（95% confidence interval，95% CI）为–0.4至0.5），无创通气期间两组的指标无显著差异（*P*=0.80）。NIV NAVA组有7例患者（35%）、对照组有10例患者（50%）需接受气管插管，组间差值为15%，95%置信区间为–15.5至4.3（*P*=0.36）。两组患者的气管插管时间、气体交换情况、生命体征、疼痛评分、治疗并发症及新生儿结局均无显著差异。**结论：** 在本试验中，NIV NAVA对早产新生儿的氧需求或有创通气需求无统计学意义上的显著影响。