Background

Approximately 15% of infants require stimulation in low-resource settings, but data on effectiveness of different stimulation approaches are limited. We aimed to compare two recommended approaches of stimulation (back rubs vs. foot flicks) in reducing the need for face-mask ventilation in newly born infants who were not crying immediately after birth in a low-resource setting.

Methods

A single center, open-label, randomized, superiority trial was conducted at St. Kizito Hospital in Matany (Uganda) between November 2019 and May 2020. Newly born infants with expected birthweight > 1500 grams who were not crying immediately after birth were randomly assigned to stimulation using back rubs or foot flicks. The primary outcome measure was the success rate of the stimulation, defined as the achievement of an effective crying preventing the need for face-mask ventilation.

Results

Success of stimulation was achieved in 76/93 neonates (82%) using back rubs and 68/93 neonates (73%) using foot flicks (risk ratio 1.12, 95% confidence interval 0.96–1.31). No procedure-associated complications arose during the study. Time to first cry was not statistically different between the two arms (mean difference −11 seconds, 95% confidence interval −39 to 18).

Conclusions

In newly born infants who were not crying immediately after birth, this trial did not provide a conclusive message in favor of back rubs or foot flicks. Nonetheless, we could not exclude a possible benefit of back rubs in avoiding the need for positive pressure ventilation and, possibly, further advanced resuscitative maneuvers.

Clinical trials registration

clinicalTrial.gov: NCT04056091.

中文翻译：

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在资源匮乏的环境中用于新生儿出生时的背部摩擦或足部轻弹：一项随机对照试验

背景

在资源匮乏的环境中，大约 15% 的婴儿需要刺激，但有关不同刺激方法有效性的数据有限。我们旨在比较两种推荐的刺激方法（背部摩擦与足部轻弹），以减少在资源匮乏环境中出生后未立即哭泣的新生婴儿对面罩通气的需求。

方法

2019 年 11 月至 2020 年 5 月在马塔尼（乌干达）的 St. Kizito 医院进行了一项单中心、开放标签、随机、优效性试验。 预期出生体重 > 1500 克且出生后没有立即哭闹的新生儿被随机分配使用背部摩擦或足部轻弹来刺激。主要结果指标是刺激的成功率，定义为有效哭泣的实现，从而避免了面罩通气的需要。

结果

76/93 新生儿 (82%) 使用背部摩擦和 68/93 新生儿 (73%) 使用足部轻弹获得成功（风险比 1.12，95% 置信区间 0.96-1.31）。研究期间没有出现与手术相关的并发症。两组之间首次哭泣的时间没有统计学差异（平均差异 -11 秒，95% 置信区间 -39 至 18）。

结论

对于出生后没有立即哭闹的新生婴儿，该试验并未提供支持揉背或足部轻弹的结论性信息。尽管如此，我们不能排除背部按摩在避免需要正压通气以及可能的进一步高级复苏操作方面的可能益处。

临床试验注册

ClinicalTrial.gov：NCT04056091。