Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to < 1.8kg: study protocol for a randomized controlled trial
Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to < 1.8kg: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-020-4101-1
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发表时间：
2020-03-19
期刊：
影响因子：
2.5
通讯作者：
Yoshida, S.
中科院分区：
文献类型：
--
作者：
Adejuyigbe, E. A.;Anand, P.;Yoshida, S.
背景全球范围内，约有15%的新生儿出生时低出生体重（LBW），这是早产或宫内生长受限或两者兼而有之的结果。这一群体中高达70%的新生儿死亡发生在出生后的头3天内。婴儿稳定后应用袋鼠妈妈护理（KMC）已被证明可使出生体重低于2.0公斤的住院婴儿的死亡率降低40%。在这些研究中，婴儿被随机分配，KMC在大约3天后开始，此时大多数新生儿死亡已经发生。本试验的目的是评价出生后尽快开始连续KMC的安全性和有效性，与目前建议的出生体重在1.0和小于1.8kg之间的新生儿在稳定后开始连续KMC相比。撒哈拉非洲。所有在这些医院分娩的孕妇都要接受预先检查。分娩后，所有出生体重在1.0至1.8 kg之间的新生儿都要接受入组筛查。符合条件的婴儿被随机分配到干预组和对照组。干预措施包括在出生后尽快开始持续的皮肤接触，促进和支持早期纯母乳喂养，以及为母亲和婴儿提供尽可能少分离的保健。这项疗效试验将主要评估出生后立即开始的KMC对新生儿死亡（入组和72小时之间的年龄和死亡之间的登记和28天的年龄）和其他关键outcomes.DiscussionThis的影响是第一个大型多国试验研究立即KMC在LMIC。这一干预措施的实施已经大大促进了低收入国家环境中的模式转变，在这种环境中，母亲在新生儿重症监护室中不与婴儿分开。该试验的结果不仅对如何在出生后立即护理LBW新生儿具有未来的全球意义，而且还将对根据母亲-新生儿重症监护病房（M-NICU）模式设计NICU的传播具有未来的全球意义。（回顾性注册）;澳大利亚新西兰临床试验注册中心（ANZCTR）：ACTRN 12618001880235（回顾性注册）。
BackgroundGlobally, about 15% of newborns are born with a low birth weight (LBW) as a result of preterm birth or intrauterine growth restriction or both. Up to 70% of neonatal deaths occur in this group within the first 3 days after birth. Kangaroo Mother Care (KMC) applied after stabilization of the infant has been shown to reduce mortality by 40% among hospitalized infants with a birth weight of less than 2.0kg. In these studies, infants were randomly assigned and KMC was initiated after about 3 days of age, when the majority of neonatal deaths would have already occurred. The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated as soon as possible after birth compared with the current recommendation of initiating continuous KMC after stabilization in neonates with a birth weight between 1.0 and less than 1.8kg.MethodsThis randomized controlled trial is being conducted in tertiary-care hospitals in five low- to middle-income countries (LMICs) in South Asia and sub-Saharan Africa. All pregnant women admitted to these hospitals for childbirth are pre-screened. After delivery, all neonates with a birth weight between 1.0 and less than 1.8kg are screened for enrollment. Eligible infants are randomly assigned to intervention and control groups. The intervention consists of continuous skin-to-skin contact initiated as soon as possible after birth, promotion and support for early exclusive breastfeeding, and provision of health care for mother and baby with as little separation as possible. This efficacy trial will primarily evaluate the impact of KMC started immediately after birth on neonatal death (between enrollment and 72h of age and deaths between enrollment and 28days of age) and other key outcomes.DiscussionThis is the first large multi-country trial studying immediate KMC in LMICs. Implementation of this intervention has already resulted in an important enhancement of the paradigm shift in LMIC settings in which mothers are not separated from their baby in neonatal intensive care units (NICUs). The findings of this trial will have future global implications not only on how the LBW newborns are cared for immediately after birth but also for the dissemination of designing NICUs in accordance with the mother-neonatal intensive care unit (M-NICU) model.Trial registrationClinical Trials Registry - India (CTRI): CTRI/2018/08/01536 (retrospectively registered); Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001880235 (retrospectively registered).