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
Open Access
- 19 March 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 21 (1), 1-13
- https://doi.org/10.1186/s13063-020-4101-1
Abstract
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. 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. 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. Clinical Trials Registry - India (CTRI): CTRI/2018/08/01536 (retrospectively registered); Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001880235 (retrospectively registered).Other Versions
Funding Information
- Bill and Melinda Gates Foundation (Investment ID OPP 1151718)
This publication has 22 references indexed in Scilit:
- Global, regional, and national causes of child mortality in 2000–13, with projections to inform post-2015 priorities: an updated systematic analysisThe Lancet, 2014
- Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost?The Lancet, 2014
- Randomized Control Trial of Kangaroo Mother Care in Low Birth Weight Babies at a Tertiary Level HospitalJournal of Nepal Paediatric Society, 2014
- Kangaroo Mother Care in Kangaroo ward for improving the growth and breastfeeding outcomes when reaching term gestational age in very low birth weight infantsActa Paediatrica, 2012
- Short duration of skin‐to‐skin contact: Effects on growth and breastfeedingJournal of Paediatrics and Child Health, 2007
- Kangaroo Mother Care: A Randomized Controlled Trial on Effectiveness of Early Kangaroo Mother Care for the Low Birthweight Infants in Addis Ababa, EthiopiaJournal of Tropical Pediatrics, 2005
- Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settingsActa Paediatrica, 1998
- Kangaroo mother method: randomised controlled trial of an alternative method of care for stabilised low-birthweight infantsThe Lancet, 1994
- Skin to skin contact for very low birthweight infants and their mothers.Archives of Disease in Childhood, 1988
- The Contribution of Low Birth Weight to Infant Mortality and Childhood MorbidityThe New England Journal of Medicine, 1985