本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00064-3

摘要内容如下：

背景

早产是全世界5岁以下儿童死亡的主要原因。世卫组织推荐袋鼠妈妈护理（KMC）；然而，它对撒哈拉以南非洲死亡率的影响及其相对成本仍不清楚。我们的目的是比较体重不超过2000 G的新生儿在临床稳定前开始的KMC与标准护理的有效性、安全性、成本和成本效益。

方法

我们在乌干达的五家医院进行了一项平行组、个体随机对照试验。年龄小于48小时、体重700-2000克、无危及生命的临床不稳定的单胎或双胎新生儿符合入选条件。我们通过计算机生成的随机分配序列，将新生儿随机（1:1）分配到稳定前开始的KMC（干预组）或标准护理（对照组），随机分配序列具有不同大小的排列块，按出生体重和招募部位分层。父母、照顾者和卫生保健工作者被告知治疗分配情况；然而，进行分析的独立统计学家被掩盖了。随机分组后，干预组的新生儿俯卧在照顾者的胸部，皮肤对皮肤，用KMC包裹固定。根据医院惯例，对照组的新生儿在保育箱或辐射加热器中接受护理；在满足稳定性标准之前，不会启动KMC。主要转归是按意向治疗分析的7天全因新生儿死亡率。经济评价从社会分类的角度评估了增量成本和成本效益。该试验已在ClinicalTrials.gov，NCT02811432注册。

调查结果

在2019年10月9日至2022年7月31日期间，2221名新生儿被随机分配:1110名（50.0%）新生儿进入干预组，1111名（50.0%）新生儿进入对照组。从随机分组到日龄7天，干预组1083名新生儿中有81名（7.5%）死亡，对照组1102名新生儿中有83名（7.5%）死亡（校正相对危险度[RR]0.97[95%CI 0.74-1.28]；P=0.85）。从随机分组到第28天，干预组1051名新生儿中有119名（11.3%）死亡，对照组1049名新生儿中有134名（12.8%）死亡（RR 0.88[0.71-1.09]；P=0.23）。即使政策制定者不重视避免新生儿死亡，从提供者的角度来看，干预措施比标准护理更具成本效益的概率为97%，从社会角度来看，这一概率为84%。

解释

在病情稳定前开始的KMC并不能降低早期新生儿死亡率；然而，从社会和提供者的角度来看，与标准护理相比，它具有成本效益。需要增加对新生儿护理的投资，以扩大影响，特别是在撒哈拉以南非洲。

英文原文如下：

Abstracts

BACKGROUND  Preterm birth is the leading cause of death in children younger than 5 years worldwide. WHO recommends kangaroo mother care (KMC); however, its effects on mortality in sub-Saharan Africa and its relative costs remain unclear. We aimed to compare the effectiveness, safety, costs, and cost-effectiveness of KMC initiated before clinical stabilisation versus standard care in neonates weighing up to 2000 g.

METHODS  We conducted a parallel-group, individually randomised controlled trial in five hospitals across Uganda. Singleton or twin neonates aged younger than 48 h weighing 700-2000 g without life-threatening clinical instability were eligible for inclusion. We randomly assigned (1:1) neonates to either KMC initiated before stabilisation (intervention group) or standard care (control group) via a computer-generated random allocation sequence with permuted blocks of varying sizes, stratified by birthweight and recruitment site. Parents, caregivers, and health-care workers were unmasked to treatment allocation; however, the independent statistician who conducted the analyses was masked. After randomisation, neonates in the intervention group were placed prone and skin-to-skin on the caregiver's chest, secured with a KMC wrap. Neonates in the control group were cared for in an incubator or radiant heater, as per hospital practice; KMC was not initiated until stability criteria were met. The primary outcome was all-cause neonatal mortality at 7 days, analysed by intention to treat. The economic evaluation assessed incremental costs and cost-effectiveness from a disaggregated societal perspective. This trial is registered with ClinicalTrials.gov, NCT02811432.

FINDINGS  Between Oct 9, 2019, and July 31, 2022, 2221 neonates were randomly assigned: 1110 (50·0%) neonates to the intervention group and 1111 (50·0%) neonates to the control group. From randomisation to age 7 days, 81 (7·5%) of 1083 neonates in the intervention group and 83 (7·5%) of 1102 neonates in the control group died (adjusted relative risk [RR] 0·97 [95% CI 0·74-1·28]; p=0·85). From randomisation to 28 days, 119 (11·3%) of 1051 neonates in the intervention group and 134 (12·8%) of 1049 neonates in the control group died (RR 0·88 [0·71-1·09]; p=0·23). Even if policy makers place no value on averting neonatal deaths, the intervention would have 97% probability from the provider perspective and 84% probability from the societal perspective of being more cost-effective than standard care.

INTERPRETATION  KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care. Additional investment in neonatal care is needed for increased impact, particularly in sub-Saharan Africa.

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