Implementation Research for Introducing Sustainable Uptake of cKMC Intervention Package in Rural Pakistan. A Community-based Cluster Randomized Controlled Trial.

An estimated 450,000 infant deaths can be prevented each year with the universal implementation of KMC at facility and community levels. The "Every Newborn Action Plan" endorsed and launched by the World Health Assembly in May 2014 includes the goal of scaling up KMC to 50% of babies weighing under 2000 grams by 2020, and to 75% of these babies by 2025(7).

Despite the availability of KMC as a cost-effective intervention its acceptance and uptake in Pakistan has been negligible. A situation analysis carried out by WHO of 12 countries in Asia and Africa to explore health system bottlenecks affecting the scale-up of KMC revealed Pakistan to be far behind other countries(8).Community ownership and health financing bottlenecks were significant challenges cited for majority of Asian countries in implementing KMC. The important barriers to KMC implementation highlighted for Pakistan were health financing, community births, lack of awareness of KMC at health care providers level, presence of sociocultural barriers, experiential and lack of effective resources including trained staff and absence of a National policy for implementation of KMC(8).

Some of the other socio-cultural factors identified at facility and community level included specific garments that most women wear which does not facilitate KMC administration, lack of support for KMC by elder members of the household. Facility bottlenecks that contributed to reduced uptake of KMC were lack of space and privacy, shortage of staff, early discharges. Majority of delivered women and babies were discharged within 6 to 12hours of childbirth.

Several studies have shown KMC as an effective intervention for the baby and mother dyad. However, majority of these studies are hospital based and require substantial investment in human resources and health system infrastructure in the Low-and Middle-Income Countries (LMIC). Currently, WHO recommends initiation of KMC in hospitals with continuation at home after discharge. However, community-initiated KMC (cKMC) is not currently a part of WHO because of lack of research into its effectiveness. For this reason, one of the top global research priorities by WHO for 2015-2025 is to assess the efficacy of community-initiated kangaroo mother care(9). Only a few studies have been conducted to address this question. One such community-based randomized controlled trial in India reported that in babies with low birthweight and no significant comorbidities, community-initiated kangaroo mother care substantially improved survival compared with usual care. (10). The study also highlighted the need for more implementation research studies in other low-income and middle-income countries to assess the feasibility of delivering the intervention effectively.

Another RCT on community-based application of KMC in rural Bangladesh did not report any difference in neonatal or infant mortality rates (11). Studies in Pakistan have been conducted to assess and review the barriers and enablers for practicing KMC in rural areas(12, 13) however, to the best of our knowledge no trial has been conducted to evaluate the impact of cKMC on newborn survival in Pakistan, where a large proportion of deliveries still take place at home. Hence it is important to evaluate efficacy and barriers to implementation of cKMC in a well-conducted community-based trial. We therefore propose to implement community Kangaroo Mother care (cKMC) in our socio-cultural context and design strategies to overcome system and community challenges. This proposed implementation trial will take a deep dive to further explore socio-cultural barriers and develop a model that can be implemented and scaled up in Pakistan. For this purpose, a cKMC package will be developed. The cKMC Package will consist of strategies to overcome socio-cultural barriers for families to practice KMC in a sustained manner in the community. The strategies include creation of KMC champions within the communities, community mobilization to create awareness using powerful IEC tools including video messages, and capacity building of health care providers on KMC and essential newborn care.