OMWaNA Operationalising kangaroo Mother care before stabilisation among low birth Weight Neonates in Africa: RCT to examine mortality impact in Uganda

全球每年有260万新生儿死亡(定义为出生后28天内死亡)，其中80%以上的死亡发生在因出生过早(早产)、小于胎龄或两者兼而有之的婴儿身上。早产并发症是全球五岁以下儿童最常见的死亡原因，但与疟疾或艾滋病毒导致的儿童死亡相比，在减少这些死亡方面的进展要慢得多。四分之三的早产死亡发生在撒哈拉以南非洲和南亚，那里的新生儿重症监护服务有限，大多数医院缺乏基本设备。据估计，仅在乌干达，每年就有45000名新生儿死亡，其中至少四分之一是由早产并发症直接造成的。袋鼠母亲护理(KMC)包括将婴儿与照顾者(通常是母亲)面对面地照顾，促进温暖和母乳喂养，并赋予母亲权力，增加母亲改善与婴儿关系的信心。KMC被发现可以将体重低于2000克的新生儿的死亡率降低40%，但这些试验只包括被认为是稳定的婴儿。世卫组织指南建议出生时体重在2000克或以下的婴儿服用KMC，一旦病情稳定，就开始服用，即不接受任何其他药物治疗。然而，大多数死亡发生在婴儿还没有稳定下来之前，伴随着呼吸困难等并发症，发生在出生后不久和没有新生儿重症监护的环境中。KMC关于稳定前婴儿存活率的唯一随机对照试验报告称，与标准护理(孵化器)相比，死亡率降低了43%。重要的是，这项试验排除了超过一半的合格婴儿，并存在其他设计问题。因此，目前没有足够的证据建议KMC在稳定之前用于小婴儿，谁可能受益最大。需要一项精心设计的试验来评估在稳定之前开始的KMC与孵化器护理相比对死亡率的影响。非洲低出生体重儿稳定前袋鼠母亲护理(OMWaNA)试验是乌干达医学研究理事会、Makerere大学和伦敦卫生和热带医学院的合作伙伴关系。在乌干达的国语中，Omwana的意思是“孩子”。这项试验的目的是确定在稳定之前开始的KMC对婴儿死亡率(7天和28天)的影响，并与2000克或更低体重的婴儿孵化器护理进行比较。在试验中，2188名尚未稳定的婴儿将被随机分配接受KMC或孵化器护理。试验将在四家没有重症监护的“典型”医院(金佳、马萨卡、伊甘加、恩德培)进行。保育箱是乌干达医院为小婴儿和早产儿保暖的标准方法，通常与几个新生儿共用。该试验还将比较KMC和孵化器护理的总体成本，同时考虑到医院的成本和家庭的成本。在稳定之前，我们将与家长和医院工作人员一起评估支持或不鼓励启动KMC的问题。此外，我们将使用一种新的调查工具来衡量乌干达照顾婴儿的妇女的生活质量。乌干达政府致力于实现一项雄心勃勃的新生儿存活全球目标，并高度重视解决新生儿死亡问题。国家新生儿指导委员会建议在卫生设施中增加KMC的规模。主要利益攸关方将参与整个试验过程，包括乌干达卫生部、乌干达儿科协会、联合国儿童基金会(总部和国家)、世卫组织和国际KMC网络。这项试验的结果将有助于在乌干达和世界各地更广泛地使用KMC，特别是在大多数婴儿死亡和无法获得新生儿重症监护的环境中。

Globally, there are 2.6 million neonatal deaths each year (defined as death during the first 28 days) and over 80% of these deaths occur in babies who are born small, due to being born too soon (preterm), being too small for their gestational age, or both. Preterm birth complications are the most common cause of death for children under age five worldwide, and yet there has been much slower progress in reducing these deaths compared to child deaths from malaria or HIV. Three-quarters of deaths due to prematurity occur in sub-Saharan Africa and south Asia, where there is limited availability of neonatal intensive care and most hospitals lack basic equipment. In Uganda alone, an estimated 45,000 newborn deaths occur annually, at least a quarter of which are directly due to complications of prematurity.Kangaroo Mother Care (KMC) involves placing the baby skin-to-skin with a caregiver, usually the mother, promoting warmth and breastfeeding and also empowering the mother, increasing maternal confidence to improve bonding with the baby. KMC has been found to reduce deaths by 40% for newborns weighing less than 2000g, but these trials included only babies that were considered to be stable. WHO guidelines recommend KMC for babies weighing 2000g or less at birth, starting as soon as they are 'stable,' i.e., not on any other medical treatments. However, the majority of deaths occur in babies before they have stabilised, with complications like breathing difficulties, soon after birth and in settings without neonatal intensive care. The only randomised controlled trial of KMC on survival amongst babies before stabilisation reported a 43% mortality reduction compared to standard care (incubators). Importantly, this trial excluded over half of eligible babies and had other design problems. Hence, there is currently not enough evidence to recommend KMC for small babies before stabilisation who could benefit the most. A well-designed trial is needed to assess the impact of KMC started before stabilisation on mortality compared to incubator care. The Operationalising kangaroo Mother care before stabilisation among low birth Weight Neonates in Africa (OMWaNA) trial is a partnership of the Medical Research Council Uganda, Makerere University, and the London School of Hygiene and Tropical Medicine. Omwana means 'child' in Uganda's national language. The aim of this trial is to determine the impact of KMC, started before stabilisation, on mortality (at 7 and 28 days) compared to incubator care in a group of babies weighing 2000g or less. In the trial, 2188 babies who are not yet stable will be assigned by chance to receive either KMC or incubator care. The trial will take place in four "typical" hospitals without intensive care (Jinja, Masaka, Iganga, Entebbe). Incubators are the standard method of keeping small and preterm babies warm in Ugandan hospitals, often with several newborns sharing. The trial will also compare the overall costs of KMC and incubator care, considering both costs to hospitals and costs to families. With parents and hospital staff, we will evaluate issues that support or discourage starting KMC before stabilisation. In addition, we will measure quality of life among women caring for small babies in Uganda with a new survey tool. The Ugandan Government committed to meeting an ambitious global goal for newborn survival and has given high priority to addressing newborn deaths. The National Newborn Steering Committee has recommended increased scale-up of KMC in health facilities. Key stakeholders will be engaged throughout the trial including the Uganda Ministry of Health, Uganda Paediatric Association, UNICEF (headquarters and country), WHO, and the International KMC Network. The findings of this trial will help inform wider use of KMC in Uganda and around the world, especially in settings where most babies die, and where neonatal intensive care is not available.