Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Department of Paediatrics, University of California San Francisco, 550 16th Street, Box 1224, San Francisco, CA, 94158, USA.
Trials. 2020 Jan 31;21(1):126. doi: 10.1186/s13063-019-4044-6.
There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in stabilised neonates; however, data on its effect among neonates before stabilisation are lacking. The OMWaNA trial aims to determine the effect of initiating KMC before stabilisation on mortality within seven days relative to standard care. Secondary objectives include exploring pathways for the intervention's effects and assessing incremental costs and cost-effectiveness between arms.
We will conduct a four-centre, open-label, individually randomised, superiority trial in Uganda with two parallel groups: an intervention arm allocated to receive KMC and a control arm receiving standard care. We will enrol 2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥ 1 therapy (e.g. oxygen). Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥ 1 baby) weighing ≥ 700-≤ 2000 g and aged ≥ 1-< 48 h are eligible. Treatment allocation is random in a 1:1 ratio between groups, stratified by weight and recruitment site. The primary outcome is mortality within seven days. Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days. Primary analyses will be by intention-to-treat. Quantitative and qualitative data will be integrated in a process evaluation. Cost data will be collected and used in economic modelling.
The OMWaNA trial aims to assess the effectiveness of KMC in reducing mortality among neonates before stabilisation, a vulnerable population for whom its benefits are uncertain. The trial will improve understanding of pathways underlying the intervention's effects and will be among the first to rigorously compare the incremental cost and cost-effectiveness of KMC relative to standard care. The findings are expected to have broad applicability to hospitals in sub-Saharan Africa and southern Asia, where three-quarters of global newborn deaths occur, as well as important policy and programme implications.
ClinicalTrials.gov, NCT02811432. Registered on 23 June 2016.
每年有 250 万新生儿死亡；其中大多数发生在出生后 48 小时内，在稳定之前。11 项试验的证据表明，袋鼠式母亲护理（KMC）可显著降低稳定新生儿的死亡率；然而，缺乏关于其在稳定前新生儿中效果的数据。OMWaNA 试验旨在确定在稳定前开始 KMC 对与标准护理相比 7 天内死亡率的影响。次要目标包括探索干预措施效果的途径，并评估臂之间的增量成本和成本效益。
我们将在乌干达进行一项四中心、开放标签、个体随机、优效性试验，分为两个平行组：干预组接受 KMC，对照组接受标准护理。我们将招募 2188 名新生儿（每组 1094 名），他们的 KMC 适应症是“不确定”，定义为接受≥1 种治疗（如吸氧）。符合条件的单胎、双胞胎和三胞胎新生儿（如果在入院前至少有 1 个婴儿死亡，则为三胞胎），体重≥700-≤2000g，年龄≥1-<48h。治疗分配在组间以 1:1 的比例随机分层，按体重和招募地点进行分层。主要结局是 7 天内死亡率。次要结局包括 28 天内死亡率、24 小时内体温过低的发生率、随机分组至稳定或死亡的时间、住院时间、随机分组至纯母乳喂养的时间、再入院频率、每日体重增加、母婴依恋和妇女在 28 天的幸福感。主要分析将按意向治疗进行。将对定量和定性数据进行整合，以进行过程评估。将收集成本数据并用于经济建模。
OMWaNA 试验旨在评估 KMC 在稳定前降低新生儿死亡率的效果，这是一个脆弱的人群，其益处尚不确定。该试验将更好地了解干预措施效果的途径，并将是首批严格比较 KMC 相对于标准护理的增量成本和成本效益的试验之一。预计研究结果将广泛适用于撒哈拉以南非洲和南亚的医院，这两个地区占全球新生儿死亡人数的四分之三，具有重要的政策和方案意义。
ClinicalTrials.gov，NCT02811432。于 2016 年 6 月 23 日注册。
