The OMWaNA Study: Operationalizing kangaroo Mother care among clinically unstable low birth Weight Neonates in Africa

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Project Summary/Abstract: Career Goals: This is a resubmission for a K23 Career Development Award for Melissa Morgan, MD, MSc, who is Assistant Professor of Pediatrics at the University of California, San Francisco (UCSF). Her previous research has centered on implementation of neonatal interventions in East Africa and India. In this award, she aims to build on her preliminary work evaluating the use of kangaroo mother care (KMC) in clinically unstable neonates in Uganda. Dr. Morgan is committed to a career in academic neonatology, focused on conducting clinical trials and health systems research to improve newborn health in low-resource settings. The skills and experience she will gain from this K23 award will prepare her to compete for an R01 proposal to conduct a randomized controlled trial (RCT) comparing the effect of KMC to incubator care on early mortality in clinically unstable neonates ≤2000 grams, with an accompanying cost-effectiveness and economic evaluation. Environment: Dr. Morgan has the full and enthusiastic support of UCSF, which has a tradition of excellence in clinical research and global health with many investigators pursuing innovative ideas in maternal and child health in low and middle-income countries. UCSF provides substantial support for junior faculty. Key Elements of Research Career Development Plan: Dr. Morgan is a neonatologist with a strong background in clinical research in low-resource settings. She has experience in study design, quantitative and qualitative data analysis, scientific writing, and managing research teams. While these experiences have provided a robust foundation, there are three areas where she requires additional training in order to achieve her career goals, including 1) advanced training in KMC and implementation science, 2) skills in cost- effectiveness and economic analysis, and 3) advanced training in statistical issues affecting clinical trials and experience conducting a pilot trial. Dr. Morgan has assembled an outstanding training and mentoring team led by her primary mentor, George Rutherford, MD, FAAP, Professor of Epidemiology, Preventive Medicine, and Pediatrics, Vice Chair of the Department of Epidemiology and Biostatistics and Director of the Prevention and Public Health Group at UCSF, who has expertise in pediatric implementation science and epidemiology in low-resource settings. Her co-mentors are Joy Lawn, MBBS, MPH, PhD, Professor and Director of the Maternal, Adolescent, Reproductive, and Child Health (MARCH) Center at the London School of Hygiene and Tropical Medicine (LSHTM), who developed the evidence base to address the global burden of neonatal mortality and played a leading role in evaluating KMC as a public health intervention, and Peter Waiswa, MBChB, MPH, PhD, Associate Professor of Health Policy and Planning and Director of the Maternal and Newborn Center of Excellence at Makerere University in Uganda, who has extensive experience employing research interventions to address neonatal mortality. Dr. Morgan’s team includes two collaborators: James Kahn, MD MPH, Professor of Health Policy and Epidemiology and Director of the Global Health Economics Consortium at UCSF, who is an expert in cost-effectiveness analysis for health interventions, and Stephen Shiboski, PhD, Professor of Biostatistics at UCSF, who has broad experience developing statistical methods for trials in Africa. She has also identified two consultants: Maya Peterson, MD, PhD, Associate Professor of Biostatistics and Epidemiology at the UC Berkeley (UCB) School of Public Health, is an expert on application of causal inference methods to observational clinical datasets. Cally Tann, MBChB, MSc, PhD, Neonatologist at University College London Hospital and Clinical Associate Professor of Child Health Development at LSHTM, has expertise in neonatology and neonatal trials, including in Uganda. Dr. Morgan is pursuing a PhD at LSHTM under the supervision of Prof. Lawn, and her training plan includes courses at UCSF, LSHTM, and UCB; directed readings and tutorials; a visit to a KMC Center of Excellence; and workshops and conferences. Description of the Research Project: There are 2.7 million neonatal deaths each year, and the majority of these occur among unstable neonates within 48 hours in low-resource settings. KMC is associated with decreased mortality among stable neonates ≤2000g. The overall aim of this study is to critically explore the use of KMC in unstable neonates in Uganda. Her central hypothesis is that, compared to incubators, KMC will reduce mortality and lead to cost savings. Aim 1 will explore factors that affect KMC uptake and duration, and use findings to develop strategies to improve KMC practice in facilities. Aim 2 will develop and implement a model to compare the incremental cost and cost-effectiveness of KMC and incubator care. In Aim 3, she will conduct a pilot trial to estimate the effect of KMC on mortality relative to incubator care and evaluate the feasibility of a full-scale RCT. Findings will inform the development of an R01 proposal for an RCT to determine the effect of KMC on mortality within 7 days compared to incubator care among unstable neonates ≤2000g. Dr. Morgan has assembled a highly experienced and well-resourced mentorship team that is committed to her proposed research and career development. Moreover, she already has a track record of productivity with her mentors. To successfully compete for an R01 and achieve independence would be the culmination of many productive and enriching clinical research experiences. The opportunities available at UCSF and through her mentoring team will prepare Dr. Morgan to become a leading neonatal clinical trialist and health systems researcher, implementing and evaluating interventions to improve newborn health in low-resource settings.