Department of Pediatrics and
Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.
Pediatrics. 2020 Dec;146(6). doi: 10.1542/peds.2020-1101.
Our aim is to compare the efficacy and safety of high-flow nasal cannula (HFNC) against those of nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV) after extubation in preterm infants.
This prospective, randomized, noninferiority trial was conducted in 6 tertiary NICUs. Infants born at <34 weeks who needed noninvasive ventilation after extubation were enrolled. We randomly assigned infants to an HFNC group when HFNC was used or to an NCPAP/NIPPV group when NCPAP or NIPPV was used. The primary outcome was treatment failure within 7 days after extubation. We then examined clinical aspects of treatment failure with HFNC use.
In total, 176 and 196 infants were assigned to the HFNC and NCPAP/NIPPV groups, respectively. The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2). Histologic chorioamnionitis ( = .02), treated patent ductus arteriosus ( = .001), and corrected gestational age at the start of treatment ( = .007) were factors independently related to treatment failure with HFNC use.
We found HFNC revealed a significantly higher rate of treatment failure than NCPAP or NIPPV after extubation in preterm infants. The independent factors associated with treatment failure with HFNC use were histologic chorioamnionitis, treated patent ductus arteriosus, and a younger corrected gestational age at the start of treatment.
本研究旨在比较经气管插管拔管后应用高流量鼻导管(HFNC)与鼻塞持续气道正压通气(NCPAP)或经鼻间歇正压通气(NIPPV)的疗效和安全性。
这是一项前瞻性、随机、非劣效性试验,在 6 家三级新生儿重症监护病房(NICU)进行。纳入需要经气管插管拔管后接受无创通气的胎龄<34 周的婴儿。当使用 HFNC 时,将婴儿随机分配到 HFNC 组,当使用 NCPAP/NIPPV 时,将婴儿随机分配到 NCPAP/NIPPV 组。主要结局为气管插管拔管后 7 天内治疗失败。然后,我们检查了 HFNC 使用时治疗失败的临床方面。
共 176 例和 196 例婴儿分别被分配到 HFNC 组和 NCPAP/NIPPV 组。HFNC 组的治疗失败率明显高于 NCPAP/NIPPV 组,HFNC 组有 54 例(31%)婴儿发生治疗失败,而 NCPAP/NIPPV 组有 31 例(16%)婴儿发生治疗失败(风险差异,14.9 个百分点;95%置信区间,6.2-23.2)。组织学绒毛膜羊膜炎( =.02)、治疗性动脉导管未闭( =.001)和开始治疗时的校正胎龄( =.007)是与 HFNC 使用治疗失败相关的独立因素。
我们发现 HFNC 经气管插管拔管后在早产儿中的治疗失败率明显高于 NCPAP 或 NIPPV。HFNC 使用治疗失败的独立相关因素为组织学绒毛膜羊膜炎、治疗性动脉导管未闭和开始治疗时的较小校正胎龄。