A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth
A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth
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DOI：
10.1016/j.resuscitation.2021.07.012
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发表时间：
2021-10-13
期刊：
影响因子：
6.5
通讯作者：
te Pas, Arjan B.
中科院分区：
文献类型：
--
作者：
van Zanten, Henriette A.;Kuypers, Kristel L. A. M.;te Pas, Arjan B.
目的：确定与不使用 RFM 相比，在极早产儿出生时进行 PPV 期间使用呼吸功能监测仪 (RFM) 是否会导致呼气潮气量 (Vte) 在预定目标范围内的充气百分比增加。方法：2013 年 10 月至 2019 年 5 月在 6 个国家的 7 个新生儿重症监护病房进行的公开随机临床试验。出生时接受 PPV 的极早产儿（妊娠 24-27 周）被随机分为可见或不可见 RFM 筛查组。主要结果是手动 PPV（面罩或插管）期间在目标范围（Vte 4-8 mL/kg）内的充气比例中位数。还有 42 项其他预先指定的监测测量和临床结果。 结果：在 288 名随机婴儿（中位 (IQR) 胎龄 26(+2) (25(+3)-27(+1)) 周）中，总共分析了 51,352 次充气。 RFM 可见组中目标范围内通货膨胀的中位数 (IQR) 百分比为 30.0 (18.0-42.2)%，而 RFM 不可见组中为 30.2 (14.8-43.1)% (p = 0.721)。其他呼吸功能测量值、氧饱和度、心率或 FiO(2) 没有差异。除了脑室内出血（所有级别）和/或囊性脑室周围白质软化的发生率（可见 RFM：26.7% vs 不可见 RFM：39.0%；RR 0.71 (0.68-0.97)；p = 0.028）外，临床结果没有差异。结论：在出生时接受 PPV 的极早产儿中，使用与没有 RFM 作为潮气量输送指导相比，RFM 并没有增加预定义目标范围内的通货膨胀百分比。
Aim: To determine whether the use of a respiratory function monitor (RFM) during PPV of extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage of inflations with an expiratory tidal volume (Vte) within a predefined target range.Methods: Unmasked, randomised clinical trial conducted October 2013 - May 2019 in 7 neonatal intensive care units in 6 countries. Very preterm infants (24-27 weeks of gestation) receiving PPV at birth were randomised to have a RFM screen visible or not. The primary outcome was the median proportion of inflations during manual PPV (face mask or intubated) within the target range (Vte 4-8 mL/kg). There were 42 other prespecified monitor measurements and clinical outcomes.Results: Among 288 infants randomised (median (IQR) gestational age 26(+2) (25(+3)-27(+1)) weeks), a total number of 51,352 inflations were analysed. The median (IQR) percentage of inflations within the target range in the RFM visible group was 30.0 (18.0-42.2)% vs 30.2 (14.8-43.1)% in the RFM non-visible group (p = 0.721). There were no dierences in other respiratory function measurements, oxygen saturation, heart rate or FiO(2). There were no dierences in clinical outcomes, except for the incidence of intraventricular haemorrhage (all grades) and/or cystic periventricular leukomalacia (visible RFM: 26.7% vs non-visible RFM: 39.0%; RR 0.71 (0.68-0.97); p = 0.028).Conclusion: In very preterm infants receiving PPV at birth, the use of a RFM, compared to no RFM as guidance for tidal volume delivery, did not increase the percentage of inflations in a predefined target range.