The OMWaNA study was a parallel-group, individually randomized controlled trial across five government hospitals in Uganda, with linked economic and process evaluations. The primary objective was to determine the effect of kangaroo mother care (KMC) initiated before stabilization on neonatal mortality relative to standard care. The secondary objective was to evaluate the intervention’s effect on other important clinical outcomes. The economic evaluation aimed to assess the incremental costs and cost-effectiveness of this intervention from a societal perspective. The process evaluation aimed to explore causal pathways for the clinical effects of KMC initiated before stabilization, and examine the barriers and facilitators to initiating KMC before stabilisation to inform uptake and sustainability.

Ultimately, we did not observe a difference in early mortality (<7 days) between neonates receiving KMC before stabilization versus those receiving standard care. However, there was a non-significant relative reduction in mortality of 12 percent at 28 days, and a pooled relative reduction in 28-day mortality of 14 percent across the six sub-Saharan African sites of all three trials of KMC before stabilization (OMWaNA, WHO Immediate KMC trial, Early KMC trial in Gambia). Additional important benefits of the intervention included a 24 percent reduction in hypothermia at 24 hours and improvements in daily weight gain at 28 days (adjusted mean difference 0.75g). Our economic evaluation indicated that KMC before stabilization was cost-effective from the societal and provider perspectives compared with standard care. The results of the OMWaNA trial and economic evaluation were published in The Lancet, and more information can be found on the LSHTM International Clinical Trials Day blog on the OMWaNA trial.