Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, encompasses a continuum that ranges from sepsis to severe sepsis, septic shock, multiple organ dysfunction syndrome (MODS) and eventually death if untreated. Sepsis is the leading cause of child mortality worldwide, with most of these deaths occurring in low and middle-income countries (LMICs) yet few clinical tools have been developed for identifying, monitoring, or managing septic children in LMICs. There is immense potential for novel clinical tools that can help clinicians more rapidly identify children with advanced stages of sepsis (severe sepsis, septic shock and MODS), who are at highest risk for decompensation and death.

Mobile health (mHealth) tools, wearable devices, and artificial intelligence (AI) technologies have rapidly proliferated across a wide range of medical applications and could serve to bridge critical gaps in care for critically ill patients in low- and middle-income settings. Dr. Garbern and Dr. Levine are working with collaborators at iccdr,b in Bangladesh to develop an mHealth clinical decision support tool that links continuous physiologic data from a wearable device with a novel machine learning approach, known as personalized physiologic analytics (PPA), run on a standard smartphone. The tool is designed to help clinicians to accurately assess sepsis severity and mortality risk in pediatric patients.

Knowledge gained from this study will greatly advance the evidence base for the use of mHealth tools and artificial intelligence techniques to help clinicians worldwide better care for critically ill children in LMIC settings earlier in the course of their disease, thereby reducing morbidity and mortality from sepsis. The results of this investigational research will be used to inform a multi-center clinical trial which would seek to assess the impact of using this mHealth tool on clinical outcomes as well as the cost-effectiveness of this tool. This tool may also provide an effective means of assessing patient responses to various therapeutic interventions via continuous physiologic monitoring in future clinical trials. The proposed initiatives will also build a base of technical and professional expertise at icddr,b in mHealth research capacity and user-centered design.

R33 Supplement for Research and Capacity Building Efforts Related to Bioethical Issues

Dr. Alicia Genisca received additional funding to complete aims related to bioethics which were built onto the parent study “Development of a Mobile Health Personalized Physiologic Analytics Tool for Pediatric Patients with Sepsis”. In the proposed research, Dr. Genisca and the team will examine and elucidate the ethical concerns of caregivers of children with sepsis eligible for enrollment in the parent study, as well as stakeholders in bioethical research decision-making (clinicians, researchers, ethical review board members, administrators), related to research using digital health technologies for clinical care among children with sepsis and critical illnesses in low- and middle-income countries.