RADX TECH FETAL MONITORING CHALLENGE AWARD – NIBIB, NICHD, AND BMGF

Investigators

Abstract

Background Fetal morbidity and mortality are major but often overlooked public health issues. Much of the public concern surrounding reproductive loss has focused on infant mortality, due in part to a paucity of knowledge of the incidence, etiology, and prevention strategies for fetal mortality. The causes and rates of fetal morbidity and mortality differ extensively across developed and less-developed countries. Since 2000, good progress has been made in reducing the stillbirth rate globally, which declined from 21.4 stillbirths per 1,000 total births in 2000 to 13.9 in 2019 – a 35% reduction. However, compared to the annual rates of reduction for other mortality indicators, the gains made in reducing stillbirths have been much slower, with progress lagging behind across all regions since 2000. Globally, there are approximately 2 million stillbirths every year with over 40% occurring after the onset of labor, the majority of which could be prevented with better quality and respectful care during childbirth. In 2014, the World Health Assembly endorsed the Every Newborn Action Plan (ENAP) which includes a global target of 12 or fewer stillbirths per 1000 total births in every country by 2030. A 2020 report from the United Nations Interagency Group for Child Mortality Estimation, estimated that 56 countries are at risk of missing the 2030 target (the majority located in sub-Saharan Africa and South Asia). Over the next decade, 20 million babies are projected to be stillborn, 2.9 million of which could be prevented by accelerating progress to meet the ENAP target in these 56 at risk countries. Within the United States, 21,000 families suffer a stillbirth each year. The five most common selected causes of fetal mortality in the U.S., by order of frequency, are: 1) fetal death of unspecified cause; 2) fetus affected by complications of placenta, cord, and membranes (e.g., fetal growth restriction); 3) fetus affected by maternal complications of pregnancy (e.g., preeclampsia and hypertension); 4) fetus affected by maternal conditions that may be unrelated to present pregnancy (e.g., diabetes); and 5) congenital malformations, deformations and chromosomal abnormalities. Additionally, fetal mortality rates continue to vary by race and ethnic origin within the U.S., being highest for Native Hawaiian or Other Pacific Islander and Black women, followed by American Indian or Alaska Native women. The rate was lowest for Asian women, followed by White and Hispanic women. Racial disparities in fetal health outcomes are persistent and well-documented, and are present in other high-income settings. Some factors contributing to these disparities include differences in maternal preconception health, socioeconomic status, access to quality health care, stress, and racism, including institutional bias. In 2022, the U.S. Congress called on the U.S. Department of Health and Human Services (HHS) to develop a task force to gather information on stillbirth, and HHS requested the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to take on this task. HHS, through its operating divisions, including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), recognizes that stillbirth is a tragedy affecting many families and communities, and action is needed to better understand and prevent these deaths. To develop a plan of action, NICHD formed the Stillbirth Working Group of the National Advisory Child Health and Human Development Council (Council). The Working Group issued a report, adopted by the Council, in March 2023 recommending the creation and support of a full research agenda, including research on known and unknown risk factors and physiologic mechanisms, to support the development of interventions to prevent stillbirth. The report called for research on ultrasound, placental function, and other types of monitoring in order to better understand what causes stillbirth and also to identify prevention opportunities. Research and development are encouraged for technologies that detect and measure markers of placental dysfunction, fetal hypoxia or acidemia, cord compression, and oxidative stress, as well as technologies that circumvent or minimize current limitations for monitoring fetal health status. What the above demonstrates is an unacceptable state of fetal health outcomes both within the U.S. and around the world that calls for immediate action and, among other changes, improvement in the diagnosis and monitoring of the physiological causes of and factors associated with fetal morbidity and mortality. In low-resource settings, a Pinard stethoscope is the most common device used for assessing fetal health status by monitoring fetal heart rate (FHR) via auscultation in both the antepartum and intrapartum period. Fetoscopes are accessible and low-cost, but can be difficult and time consuming to use. This difficulty results in health care providers forgoing the intermittent auscultation of FHR recommended during labor. In high-income settings, electronic fetal monitoring (EFM) is the standard of care. However, EFM technology, including continuous cardiotocography (cCTG), has remained largely unchanged over the last several decades. Consistent evidence gained over the last 60 years demonstrates that cCTG does not reduce the rate of fetal acidemia, cerebral palsy, or perinatal death. Additionally, Cesarean rates in the U.S. have increased from less than 5% in the 1970s to greater than 30% in settings where EFM is routinely used. The global health community is concerned about the already rising rates of Cesarean births in low-resourced settings and how the introduction of EFM may further exacerbate this issue. The combination of these factors further points to the need for technological innovations in determining fetal well-being across multiple physiological parameters during antepartum and intrapartum periods of pregnancy. The RADx Tech Fetal Monitoring Challenge seeks to spur and reward the development of innovative and accessible technologies that can help improve fetal and neonatal health outcomes through earlier and more accurate diagnosis, detection, monitoring of fetal health status and appropriate intervention. Challenge Design Innovators participating in the RADx Tech Fetal Monitoring Challenge will initially submit a proposal describing in detail their fetal health diagnostic or monitoring technology, anticipated clinical impact, and plans for continued development and implementation in low-resource settings. Innovators must already have developed a working prototype with data demonstrating the proof of concept. Technologies at the conceptual design or idea stage will not be considered responsive and are unlikely to be selected to advance. For the initial proposal submission, Innovators must also provide a robust proposal for further development of the technology to meet the program’s criteria. These proposals will be reviewed during Phase 1 of the Challenge from which up to winners will be selected as semi-finalists, receive a cash prize of $5,000 each, and be invited to advance to Phase 2. Only winners of Phase 1 will be eligible to compete in Phase 2. During this Phase 2, Innovators will deliver a live presentation and demonstration of the technology as well as plans for further maturation and implementation in low-resource settings; this event will take place on the NIH campus in Bethesda, MD. The presentations will be evaluated by a panel composed of scientific/technical, clinical, regulatory, and commercialization experts from NIH, the Bill & Melinda Gates Foundation, and other organizations under contract with NIBIB through the RADx Tech program. Up to 6 winners of Phase 2 will be selected as finalists to receive a cash prize of $75,000 each and advance to Phase 3 of the Challenge. During the third and final Phase of the Challenge, a RADx Tech Project Team of healthcare technology commercialization and content experts will engage directly with each Innovator to assess the prototype technology across and will work with NIH to identify key risk factors for accelerated development and implementation and establish strategies to mitigate these risks, subject to final decisions by NIH. The objective of this Phase is to support Innovators as they rapidly advance the development of their technologies over a period of approximately 6 months and increase their likelihood for reducing fetal morbidity and mortality. Innovators in this final Phase will compete for additional cash prizes ranging from $50,000 - $750,000 each. Technology Requirements Diagnostic or monitoring technologies submitted to the RADx Tech Fetal Monitoring Challenge must: • At a minimum, be a working prototype of a technology with data demonstrating the proof of concept. • Directly detect and measure one or more physiological parameters of the fetus itself. Technologies that detect and measure physiological abnormalities of the umbilical cord or placenta will also be considered within scope. • Measure one or more parameters of fetal health status during the late antepartum and/or intrapartum periods of pregnancy. Technologies may have utility in earlier stages of gestation as well, but only those that yield clinically actionable information in the later stages of gestation or during labor and delivery will be considered within scope. • Be either noninvasive or minimally invasive. • Be implementable at the point-of-care by a clinician or healthcare technician/provider in a hospital, clinic, or a community healthcare setting, or in an at-home setting by a caregiver or even ultimately the pregnant person themselves. • Have a reasonable likelihood of market entry within the next 5 years. • Have strong potential for accessible, cost-effective use and impact in low-resource settings, such as low- and middle-income countries as well as areas of high-income countries where there is limited access to quality prenatal healthcare. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Bill & Melinda Gates Foundation (Gates Foundation) are co-sponsoring this Challenge. Source: https://www.challenge.gov/?challenge=radx-tech-fetal-monitoring