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

Trials. 2020 Mar 19;21(1):280. doi: 10.1186/s13063-020-4101-1.


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).

Keywords: Breastfeeding; Immediate Kangaroo Mother Care (iKMC); Low-birth-weight babies; Mortality; Mother-neonatal intensive care unit (M-NICU); Skin-to-skin contact.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Adult
  • Africa South of the Sahara
  • Asia
  • Birth Weight / physiology*
  • Breast Feeding
  • Female
  • Humans
  • Infant
  • Infant Mortality*
  • Infant, Low Birth Weight / growth & development*
  • Infant, Newborn
  • Intensive Care Units, Neonatal
  • Kangaroo-Mother Care Method / methods*
  • Length of Stay
  • Multicenter Studies as Topic
  • Parturition
  • Pregnancy
  • Randomized Controlled Trials as Topic
  • Weight Gain
  • Young Adult