Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial

Abstract

BackgroundAround 70% neonatal deaths occur in low birth weight (LBW) babies. Globally, 15% of babies are born with LBW. Kangaroo Mother Care (KMC) appears to be an effective way to reduce mortality and morbidity among LBW babies. KMC comprises of early and continuous skin-to-skin contact between mother and baby as well as exclusive breastfeeding. Evidence derived from hospital-based studies shows that KMC results in a 40% relative reduction in mortality, a 58% relative reduction in the risk of nosocomial infections or sepsis, shorter hospital stay, and a lower risk of lower respiratory tract infections in babies with birth weight <2000 g. There has been considerable interest in KMC initiated outside health facilities for LBW babies born at home or discharged early. Currently, there is insufficient evidence to support initiation of KMC in the community (cKMC). Formative research in our study setting, where 24% of babies are born with LBW, demonstrated that KMC is feasible and acceptable when initiated at home for LBW babies. The aim of this trial is to determine the impact of cKMC on the survival of these babies.Methods/designThis randomized controlled trial is being undertaken in the Palwal and Faridabad districts in the State of Haryana, India. Neonates weighing 1500–2250 g identified within 3 days of birth and their mothers are being enrolled. Other inclusion criteria are that the family is likely to be available in the study area over the next 6 months, that KMC was not initiated in the delivery facility, and that the infant does not have an illness requiring hospitalization. Eligible neonates are randomized into intervention and control groups. The intervention is delivered through home visits during the first month of life by study workers with a background and education similar to that of workers in the government health system. An independent study team collects mortality and morbidity data as well as anthropometric measurements during periodic home visits. The primary outcomes of the study are postenrollment neonatal mortality and mortality between enrollment and 6 months of age. The secondary outcomes are breastfeeding practices; prevalence of illnesses and care-seeking practices for the same; hospitalizations; weight and length gain; and, in a subsample, neurodevelopment.DiscussionThis efficacy trial will answer the question whether the benefits of KMC observed in hospital settings can also be observed when KMC is started in the community. The formative research used for intervention development suggests that the necessary high level of KMC adoption can be reached in the community, addressing a problem that seriously constrained conclusions in the only other trial in which researchers examined the benefits of cKMC.Trial registrationClinicalTrials.gov identifier: NCT02653534. Registered on 26 December 2015 (retrospectively registered).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1991-7) contains supplementary material, which is available to authorized users.

Quality of Kangaroo Mother Care services in Ethiopia: Implications for policy and practice

“…Staffing shortages and poor staffing support also hindered providers’ ability to supervise KMC and provide mothers with the necessary counseling [9, 19–21]. KMC is a complex intervention with multiple elements that requires careful follow-up and monitoring by health care providers to identify potential newborn complications and manage them promptly [9, 11, 20, 22]. Dedicating adequate space for KMC and improving staffing and training on KMC is necessary to improve LBW babies’ outcomes in Ethiopia.…”

Does kangaroo mother care have an impact on morbidity, mortality and duration of hospital stay of newly born low birth weight babies?

“…Of the estimated 4 million neonatal deaths, LBW/preterm infants accounts for more than 33%, hypothermia and infections are frequent aggravating factors for poor outcome of premature / LBW babies. 6 In this study, KMC group 52% of weight gain was in between 100-200 gm, while in control group 52% of weight gain was in between 0-100 gm. Babies in KMC has a better average weight gain per day as compared to the control group.…”

Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial

“…In the study sites, around 40% were home births and around one-fourth of all babies were born with LBW. Details of the study settings have been published elsewhere [23].…”

“…All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers (Accredited Social Health Activists; ASHAs) as implemented through the health system [24]. Specific details of the intervention have been published elsewhere [23].…”