Rapid Interventions to Save Newborn LivEs (R.I.S.E)
Mainga Hamaluba, Head of Clinical Research at the KEMRI-Wellcome Trust Research Programme in Kenya, will develop a pragmatic adaptive trial platform to evaluate key interventions for improving child survival in East Africa in real-life routine practice conditions as a faster and lower-cost alternative to traditional randomized controlled trials. Dr. Hamaluba has led a wide-range of complex clinical trials, including oversight of a complement of COVID-19 prevention and vaccine trials. She will use newborn care and hypoxic-ischaemic encephalopathy (HIE; also known as birth asphyxia) as a case study for the platform. HIE is the leading cause of admission in a network of Newborn Units in Kenya and causes severe neurological disabilities in survivors. Leveraging an existing and unique clinical surveillance framework and biobank at her institute, she will conduct a pragmatic platform adaptive randomized controlled trial of three licensed treatments to evaluate their effect on newborn survival. She will also establish procedures to increase the speed, rigor, and adaptability of regulatory approval protocols for clinical trials, and focus on training and mentorship of local healthcare workers in clinical research.