Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to < 1.8 kg: study protocol for a randomized controlled trial

Abstract

Background Globally, 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 2.0 kg. 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 1.8 kg. Methods This 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 1.8 kg 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 72 h of age and deaths between enrollment and 28 days of age) and other key outcomes. Discussion This 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 registration Clinical Trials Registry - India (CTRI): CTRI/2018/08/01536 (retrospectively registered); Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001880235 (retrospectively registered).

Preterm care during the COVID-19 pandemic: A comparative risk analysis of neonatal deaths averted by kangaroo mother care versus mortality due to SARS-CoV-2 infection

“…Our estimates are conservative since we have used the worst-case COVID-19 mortality impact yet the least effects for KMC, only considering survival benefit, not disability-adjusted life years or developmental outcomes. Furthermore, we did not consider the additional impact of initiating KMC before stabilisation [38] , [39] , [40] or implementation at a community-level [41] . Hence these estimates might underestimate the potential magnitude of these benefits and also other evidence-based newborn care practices, such as delayed cord clamping [42] .…”

Recuperación del neonato de bajo peso: relevancia de las UCIN de puertas abiertas

“…El aumento de peso está relacionado con el contacto piel a piel que favorece el MMC ya que este tiene el potencial de afectar el crecimiento de múltiples maneras: promoviendo la digestión y la absorción de la nutrición, así como bloqueando la activación del eje hipotalámico-hipofisiario-adrenal y del sistema nervioso sim pático y sus efectos perjudiciales sobre el crecimiento. Los investigadores han encontrado que los bebés que reciben una intervención de MMC tienen un mayor aumento de peso diario promedio y un mejor crecimiento semanal en la circunferencia y longitud de la cabeza (27)(28)(29)(30).…”

Kangaroo mother care knowledge, attitude, and practice among nursing staff in a hospital in Jakarta, Indonesia

“…Providing actual training to the nursing staff shows promise of substantially improving KMC implementation at Koja District Hospital. Also, the lack of training could result in conflicting knowledge on the timing and duration of KMC [ 14 , 15 ], which could lead to adverse consequences such as mortality [ 16 ] especially among less stable infants.…”