Kangaroo mother care prior to stability for neonates weighing ≤2000 grams: implementation evaluation in Uganda

Preterm birth and in-utero growth restriction, leading to premature and small-for-gestational-age infants, are major causes of neonatal mortality, especially in sub-Saharan Africa, where progress in reducing neonatal mortality has been slow. Kangaroo Mother Care (KMC) is an evidence-based intervention that improves survival and other outcomes in low-birth-weight neonates. At the start of this PhD, there were significant evidence gaps around initiating KMC prior to clinical stability, its impact in lower-level neonatal units (WHO level 2), and the challenges of scaling up this intervention. Prior to clinical stability was defined as receiving at least one therapy: oxygen, intravenous fluids, antibiotics, or anti-seizure medicines. In addition, there was a lack of validated methods for measuring KMC duration, despite its documented importance for clinical outcomes. The primary aim of this PhD was to generate evidence on the processes and requirements to safely implement KMC before clinical stabilisation, to evaluate its impact on mortality among neonates weighing ≤2000g and assess the methods used to measure KMC duration. The objectives were to: (1) examine the impact of KMC prior to clinical stability on mortality and other clinical outcomes amongst neonates ≤2000g at five Ugandan hospitals from an implementation perspective; (2) review existing evidence on KMC duration measurement methods; (3) validate KMC duration measurement methods against an independent observer as a gold standard; and (4) explore barriers and facilitators to initiating KMC in government hospitals to inform future uptake and sustainability. This PhD was embedded within the OMWaNA trial a randomised controlled trial that examined the mortality effect of KMC prior to clinical stabilisation amongst newborns weighing ≤2000 grams. The thesis first outlines the study's rationale and describes the trial site preparations, including expanding facilities to accommodate KMC beds, bathrooms for caregivers and oxygen supply points. All five hospitals remodeled existing spaces or built new ones, requiring significant infrastructure and staffing investments. These findings raise critical questions about the affordability and feasibility of rapidly scaling immediate KMC, while also providing essential evidence to guide investment decisions and context-specific strategies for implementation in low-and middle-income countries (LMICs). It also presents the findings of the OMWaNA trial that demonstrated the positive effect of providing earlier and longer durations of KMC prior to stability on neonatal mortality when compared to standard care. Within the intervention group, infants who received a median of 12–24 hours of KMC per day had a significantly lower risk of death both at 7 days (0·17 [0·07–0·43]; p=0·0001) and at 28 days (0·19 [0·10–0·38]; p<0·0001) than those who received up to 12 hours of KMC daily. The second part of this thesis reviews the evidence on KMC duration measurement. It presents findings from a scoping review of 213 publications, highlighting the lack of validation of the commonly used methods of caregiver reports and healthcare worker records. In addition, it includes results from a validation study comparing these methods against independent observations as a gold standard. The final section identifies key facilitators and barriers to KMC implementation before clinical stability, such as family support, infrastructure improvements, and healthcare worker training. This PhD research has provided valuable evidence on the implementation of Kangaroo Mother Care prior to clinical stability, assessing its impact on mortality, evaluating KMC measurement methods, and identifying the key facilitators and barriers to its implementation. The findings underscore the need for significant investment in neonatal care infrastructure and workforce and will help shape WHO's recommendation to start KMC immediately after birth across all levels of care.