BACKGROUND Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as continuous skin-to-skin contact for 18 h per day to fully stabilised neonates ≤ 2000 g, reduces mortality by 36-51% at discharge or term-corrected age compared with incubator care. The mortality effect of starting continuous KMC before stabilisation is a priority evidence gap, which we aim to investigate in the eKMC trial, with a secondary aim of understanding mechanisms, particularly for infection prevention. METHODS We will conduct a single-site, non-blinded, individually randomised, controlled trial comparing two parallel groups to either early (within 24 h of admission) continuous KMC or standard care on incubator or radiant heater with KMC when clinically stable at > 24 h of admission. Eligible neonates (n = 392) are hospitalised singletons or twins < 2000 g and 1-24 h old at screening who are mild to moderately unstable as per a trial definition using cardio-respiratory parameters. Randomisation is stratified by weight category (< 1200 g; ≥ 1200 g) and in random permuted blocks of varying sizes with allocation of twins to the same arm. Participants are followed up to 28 ± 5 days of age with regular inpatient assessments plus criteria-led review in the event of clinical deterioration. The primary outcome is all-cause neonatal mortality by age 28 days. Secondary outcomes include the time to death, cardio-respiratory stability, hypothermia, exclusive breastfeeding at discharge, weight gain at age 28 days, clinically suspected infection (age 3 to 28 days), intestinal carriage of extended-spectrum beta-lactamase producing (ESBL) Klebsiella pneumoniae (age 28 days), and duration of the hospital stay. Intention-to-treat analysis will be applied for all outcomes, adjusting for twin gestation. DISCUSSION This is one of the first clinical trials to examine the KMC mortality effect in a pre-stabilised preterm population. Our findings will contribute to the global evidence base in addition to providing insights into the infection prevention mechanisms and safety of using this established intervention for the most vulnerable neonatal population. TRIAL REGISTRATION ClinicalTrials.gov NCT03555981. Submitted 8 May 2018 and registered 14 June 2018. Prospectively registered.

中文翻译：

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冈比亚早期袋鼠母亲护理与标准护理对稳定前早产新生儿生存率的随机试验方案 (eKMC)。

背景技术早产并发症每年导致超过 100 万人死亡，其中大多数是在出生后第一天（47%）和产后完全稳定之前。与保温箱护理相比，袋鼠妈妈护理 (KMC) 通过每天 18 小时持续皮肤接触，为完全稳定的 ≤ 2000 克的新生儿提供出院或足月校正年龄时的死亡率降低 36-51%。在稳定之前开始连续 KMC 对死亡率的影响是一个优先的证据差距，我们的目的是在 eKMC 试验中调查这一点，第二个目的是了解机制，特别是感染预防的机制。方法 我们将进行一项单中心、非盲法、单独随机、对照试验，比较两个平行组与早期（入院 24 小时内）持续 KMC 或当临床稳定在 > 24 时在培养箱或辐射加热器上使用 KMC 的标准护理入学时的h。符合条件的新生儿 (n = 392) 是筛查时年龄小于 2000 g、年龄为 1-24 小时的住院单胎或双胞胎，根据使用心肺参数的试验定义，这些新生儿属于轻度至中度不稳定。随机化按体重类别（< 1200 g；≥ 1200 g）分层，并按不同大小的随机排列块进行分层，并将双胞胎分配到同一臂。参与者在 28 ± 5 天大时接受定期住院评估，并在临床恶化时进行以标准为主导的审查。主要结局是 28 天时的全因新生儿死亡率。次要结局包括死亡时间、心肺稳定性、体温过低、出院时纯母乳喂养、28 天时体重增加、临床怀疑感染（3 至 28 天）、肠道携带超广谱 β-内酰胺酶（ESBL） ) 肺炎克雷伯菌（28 天），以及住院时间。意向治疗分析将适用于所有结果，并针对双胎妊娠进行调整。讨论 这是首批检验 KMC 对预先稳定的早产人群死亡率影响的临床试验之一。我们的研究结果除了提供对感染预防机制和对最弱势新生儿群体使用这种既定干预措施的安全性的见解之外，还将为全球证据库做出贡献。试验注册 ClinicalTrials.gov NCT03555981。2018 年 5 月 8 日提交，2018 年 6 月 14 日注册。预期注册。