Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

Methods

A multicentre, randomised controlled trial.

一项多中心、随机对照试验。

Twenty tertiary neonatal intensive care units in China.

中国有20个三级新生儿重症监护病房。

342 extremely preterm infants (gestational age between 24 weeks +0 day and 28 weeks +6 days) with respiratory distress syndrome were enrolled in the study between August 2022 and August 2024.

研究在2022年8月至2024年8月期间纳入了342名患有呼吸窘迫综合征的极早产儿（胎龄在24周0天至28周6天之间）。

Participants were randomly allocated to receive NCPAP or NHFOV as primary respiratory support for respiratory distress syndrome.

参与者被随机分配接受持续气道正压通气（NCPAP）或高频振荡通气（NHFOV）作为呼吸窘迫综合征的主要呼吸支持。

The primary outcome was treatment failure, defined as the need for invasive mechanical ventilation within 72 hours after birth.

主要结果是治疗失败，定义为出生后72小时内需要侵入性机械通气。

Results

Treatment failure within 72 hours occurred in 27 of` 170 infants (15.9%) in the NHFOV group and 48 of 172 infants (27.9%) in the NCPAP group (risk difference -12.0 percentage points, 95% confidence interval-20.7 to -3.4; P=0.007).

在NHFOV组的170名婴儿中，有27名（15.9%）在72小时内治疗失败，而在NCPAP组的172名婴儿中，有48名（27.9%）治疗失败（风险差异-12.0个百分点，95%置信区间-20.7至-3.4；P=0.007）。

Treatment failure within seven days was also lower in the NHFOV group (-12.5 percentage points, 95% confidence interval-21.9 to -3.2; P=0.008) compared with the NCPAP group.

与NCPAP组相比，NHFOV组在七天内的治疗失败率也较低（-12.5个百分点，95%置信区间-21.9至-3.2；P=0.008）。

All observed associations remained significant after sensitivity analysis including study sites and antenatal steroid use.

在包括研究地点和产前类固醇使用情况的敏感性分析后，所有观察到的关联仍然显著。

No significant differences were found in any other secondary outcomes between the two groups.

在两组之间未发现任何其他次要结果的显著差异。

Conclusions

NHFOV appeared superior to NCPAP in reducing the need for intubation when used as a primary respiratory support strategy in extremely preterm infants.

在作为极早产儿主要呼吸支持策略时，高频振荡通气（NHFOV）似乎比鼻塞持续气道正压通气（NCPAP）更能减少插管的需求。

Both techniques did not show significant differences in neonatal adverse events.

这两种技术在新生儿不良事件方面没有显示出显著差异。

trial_registration

ClinicalTrials.gov NCT05141435.

ClinicalTrials.gov NCT05141435。