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NIV NAVA 与经鼻持续气道正压通气(NCPAP)治疗早产儿的随机临床试验。

NIV NAVA versus Nasal CPAP in Premature Infants: A Randomized Clinical Trial.

机构信息

PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland,

Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland,

出版信息

Neonatology. 2019;116(4):380-384. doi: 10.1159/000502341. Epub 2019 Sep 5.

DOI:10.1159/000502341
PMID:31487718
Abstract

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.

摘要

背景

为避免有创通气的不良影响,推荐对新生儿呼吸窘迫使用无创通气。

目的

本研究旨在比较经鼻神经调节辅助通气(NIV NAVA)和持续气道正压通气(CPAP)在早产儿中的可行性。

方法

40 例胎龄 28+0 至 36+6 周、生后<48 h 需 CPAP 和补充氧(FiO2>0.23)治疗呼吸窘迫的早产儿,随机分为 NIV NAVA 组或 CPAP 组。主要终点为纳入研究后 12 h 的吸入氧浓度。次要终点为氧疗时间、总呼吸支持时间、肠外营养、血气值、患儿舒适度、有创通气需求和治疗并发症。

结果

两组入组时的平均 FiO2 为 0.29。治疗 12 h 后,FiO2 分别为 0.26±0.07 和 0.26±0.04(组间差异 0.006,95%CI -0.4 至 0.5),在无创通气过程中两组间无差异(p=0.80)。NIV NAVA 组 7 例(35%)和 CPAP 组 10 例(50%)患儿需插管(差异 15%,95%CI -15.5 至 4.3,p=0.36)。插管时间、气体交换、生命体征、疼痛评分、治疗并发症和新生儿结局在两组间无差异。

结论

在本试验中,NIV NAVA 对早产儿的氧需求或有创通气需求无统计学显著影响。

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